clia waived tests and cpt codes

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DOH 681-018 April 2017 Page 1 of 47 Waived Tests and CPT Codes This list is for informational purposes only and may not accurately represent current CMS CPT codes. Please verify your tests waived status and CPT code prior to implementing testing. Test Name/Specific Test System Manufacturer Approved CPT Code(s) Adenovirus AdenoPlus (human eye fluid) Rapid Pathogen Screening, Inc. 87809QW Rapid Pathogen Screening RPS Adeno Detector Rapid Pathogen Screening, Inc. 87809QW Aerobic/Anaerobic Organisms - Vaginal Genzyme Diagnostics OSOM BVBLUE Test Gryphus Diagnostics, LLC 87905QW Gryphus Diagnostics BVBlue Gryphus Diagnostics, LLC 87905QW OBGYN-Vph Vaginal Ph Screening Kit Teco Diagnostics Pending Aerobic/Anaerobic/Viral Panel - Respiratory FilmArray Respiratory Panel 2.0 EZ (RP EZ) (nasopharyngeal) Biofire Diagnostics, LLC Pending Albumin Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP, Renal) Abaxis, Inc 82040QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) Abaxis, Inc. 82040QW Abaxis Piccolo xpress Chem Analyzer WB (Chem 13, CMP, Liver Panel Plus, Renal) Abaxis, Inc 82040QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82040QW Genzyme Diag OSOM ImmunoDip (urinary alb) Genzyme Diagnostics 82040QW HemoCue Albumin 201 System (urinary albumin) HemoCue AB 82040QW Alanine Aminotransferase (ALT) Abaxis Piccolo Blood Chem Analyzer WB (CMP, Chem 6, Chem 13) Abaxis, Inc 84460QW Abaxis Piccolo Point Of Care Chemistry Analyzer (Lipid Panel Reagent Disc) ALT Abaxis, Inc. 84460QW Abaxis Piccolo xpress Chem Analyzer WB(CMP, Lipid Panel Plus, Liver Panel Plus, Chem 6, Chem 13) Abaxis, Inc 84460QW Alere Cholestech LDX (ALT)(WB) Alere, Inc 84466QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Arkray, Inc. / Polymedco, Inc 84460QW Cholestech LDX Alanine Aminotransferase (ALT) Cholestech Corporation 84460QW Alkaline Phosphatase (ALP) Abaxis Piccolo Blood Chem Analyzer WB (CMP, Chem 13) Abaxis, Inc 84075QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) (WB) Abaxis, Inc. 84075QW Abaxis Piccolo xpress Chem Analyzer WB (CMP, Chem 13, Liver Panel Plus) Abaxis, Inc 84075QW Akray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 84075QW Amylase Abaxis Piccolo Blood Chem Analyzer WB (Chem 13) Abaxis, Inc 82150QW Abaxis Piccolo express Chemistry Analyzer WB (Liver Panel Plus, Chem 13) Abaxis, Inc 82150QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc)(WB) Abaxis, Inc. 82150QW Aspartate Aminotransferase (AST) Abaxis Piccolo Blood Chem Analyzer WB (Chem 6, Chem 13, CMP) Abaxis, Inc 84450QW

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Page 1: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 1 of 47

Waived Tests and CPT Codes This list is for informational purposes only and may not accurately represent current CMS CPT codes.

Please verify your tests waived status and CPT code prior to implementing testing.

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Adenovirus AdenoPlus (human eye fluid) Rapid Pathogen Screening, Inc. 87809QW Rapid Pathogen Screening RPS Adeno Detector Rapid Pathogen Screening, Inc. 87809QW

Aerobic/Anaerobic Organisms - Vaginal Genzyme Diagnostics OSOM BVBLUE Test Gryphus Diagnostics, LLC 87905QW Gryphus Diagnostics BVBlue Gryphus Diagnostics, LLC 87905QW OBGYN-Vph Vaginal Ph Screening Kit Teco Diagnostics Pending

Aerobic/Anaerobic/Viral Panel - Respiratory FilmArray Respiratory Panel 2.0 EZ (RP EZ) (nasopharyngeal) Biofire Diagnostics, LLC Pending Albumin

Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP, Renal) Abaxis, Inc 82040QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) Abaxis, Inc. 82040QW

Abaxis Piccolo xpress Chem Analyzer WB (Chem 13, CMP, Liver Panel Plus, Renal) Abaxis, Inc 82040QW

Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82040QW Genzyme Diag OSOM ImmunoDip (urinary alb) Genzyme Diagnostics 82040QW HemoCue Albumin 201 System (urinary albumin) HemoCue AB 82040QW

Alanine Aminotransferase (ALT) Abaxis Piccolo Blood Chem Analyzer WB (CMP, Chem 6, Chem 13) Abaxis, Inc 84460QW

Abaxis Piccolo Point Of Care Chemistry Analyzer (Lipid Panel Reagent Disc) ALT Abaxis, Inc. 84460QW

Abaxis Piccolo xpress Chem Analyzer WB(CMP, Lipid Panel Plus, Liver Panel Plus, Chem 6, Chem 13) Abaxis, Inc 84460QW

Alere Cholestech LDX (ALT)(WB) Alere, Inc 84466QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Arkray, Inc. / Polymedco, Inc 84460QW Cholestech LDX Alanine Aminotransferase (ALT) Cholestech Corporation 84460QW

Alkaline Phosphatase (ALP) Abaxis Piccolo Blood Chem Analyzer WB (CMP, Chem 13) Abaxis, Inc 84075QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) (WB) Abaxis, Inc. 84075QW

Abaxis Piccolo xpress Chem Analyzer WB (CMP, Chem 13, Liver Panel Plus) Abaxis, Inc 84075QW

Akray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 84075QW Amylase

Abaxis Piccolo Blood Chem Analyzer WB (Chem 13) Abaxis, Inc 82150QW Abaxis Piccolo express Chemistry Analyzer WB (Liver Panel Plus, Chem 13) Abaxis, Inc 82150QW

Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc)(WB) Abaxis, Inc. 82150QW

Aspartate Aminotransferase (AST) Abaxis Piccolo Blood Chem Analyzer WB (Chem 6, Chem 13, CMP) Abaxis, Inc 84450QW

Page 2: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 2 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Abaxis Piccolo Point Of Care Chemistry Analyzer (Liver Panel Reagent Disc) AST (WB) Abaxis, Inc. 84450QW

Abaxis Piccolo xpress Chem Analyzer WB(Chem 6, Chem 13, CMP, Liver Panel Plus, Lipid Panel Plus) Abaxis, Inc 84450QW

Arkray SPOTCHEM EZ Chem Analyzer (WB) Arkray, Inc. / Polymedco, Inc 84450QW Cholestech LDX Aspartate Aminotransferase Cholestech Corporation 84450QW

B-Type Natriuretic Peptide (BNP) Biosite Triage Meter (WB) (BNP) Biosite Incorporated 83880QW Biosite Triage Meter Plus (WB)(BNP) Biosite Incorporated 83880QW Biosite Triage Meterpro (WB)(BNP) Biosite Incorporated 83880QW

Basic Metabolic Panel (Calcium, Ionized) Abbott i-STAT CHEM8+ Cartridge WB I-STAT Corporation 80047QW

Basic Metabolic Panel (Calcium, Total) Abaxis Piccolo Blood Chemistry Analyzer WB (Basic Metabolic Reagent Disc) Abaxis, Inc 80048QW

Abaxis Piccolo xpress Chemistry Analyzer WB (Basic Metabolic Reagent Disc) Abaxis, Inc 80048QW

Bilirubin, Total Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP) Abaxis, Inc 82247QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc)(WB) Abaxis, Inc. 82247QW

Abaxis Piccolo xpress Chem Analyzer WB(Chem 13, CMP, Liver Panel Plus) Abaxis, Inc 82247QW

Akray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82247QW Bladder Tumor Associated Antigen

Alere NMP22 BladderChek Test Alere 86386QW BTA stat Test (for home use) Bion Diagnostic Sciences 86294QW LifeScan Status BTA Polymedco, Inc 86294QW Maritech BladderCheck Maritech, Inc. 86386QW

BUN (Blood Urea Nitrogen) Abaxis Piccolo Blood Chemistry Analyzer (Chem 6 and 13 Panels, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 84520QW

Abaxis Piccolo xpress Chemistry Analyzer WB (Chem 6, 13, Kidney Panels, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 84520QW

Abbott i-STAT 6+ Cartridge (WB) i-STAT Corporation 84520QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 84520QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Arkray, Inc. 84520QW

Calcium Abaxis Piccolo Blood Chemistry Analyzer WB (Chem 13 Panel, CMP, BMP, Renal) Abaxis, Inc. 82310QW

Abaxis Piccolo xpress Chemistry Analyzer WB (Chem 13 Panel, CMP, BMP, Renal) Abaxis, Inc. 82310QW

Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82310QW Calcium – Ionized

Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82330QW Carbon Dioxide (CO2)

Abaxis Piccolo Blood Chemistry Analyzer (CMP, BMP, Electrolyte Discs, Metlyte 8, Renal) Abaxis, Inc 82374QW

Page 3: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 3 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Abaxis Piccolo xpress Chemistry Analyzer (CMP, BMP, Electrolyte Discs, Metlyte 8, Renal) Abaxis, Inc 82374QW

Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82374QW Catalase

Accutest Uriscreen Rapid UTI Screen Savyon Diagnostics 81007QW Uriscreen (for OTC use), urine Diatech Diagnostics 81007QW

Chloride Abaxis Piccolo Blood Chemistry Analyzer (CMP, BMP, Electrolyte, Metlyte 8, Renal) Abaxis, Inc 82435QW

Abaxis Piccolo xpress Chemistry Analyzer (CMP, BMP, Electrolyte, Metlyte 8, Renal) Abaxis, Inc 82435QW

Abbott i-STAT 6+ Cartridge (WB) i-STAT Corporation 82435QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82435QW

Cholesterol Abaxis Piccolo xpress Chemistry Analyzer {capillary-finger stick} (Cholesterol) Abaxis, Inc 82465QW

Abaxis Piccolo xpress Chemistry Analyzer WB (Lipid Panel, Lipid Panel Plus) Abaxis, Inc 82465QW

Abaxis Piccolo Point of Care Chemistry Analyzer WB (Lipid Panel, Lipid Panel Plus) Abaxis, Inc 82465QW

Accu-Check InstantPlus Cholesterol Test System Roche/Boehringer Mannheim 82465QW Accucheck Instant Plus Dual Testing System Roche Diagnostics 82465QW Advanced Care Cholesterol Measuring System Johnson & Johnson 82465QW Alere Cholestech LDX (cholesterol)(WB) Alere, Inc 84465QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82465QW Biomedix Inc Q Steps Biometer G/C Dual Monitoring System Biomedix, Inc. 82465QW ChemTrak AccuMeter Cholesterol Test System ChemTrak 82465QW Cholestech LDX (Must have software version 1.40 or above) Cholestech 82465QW ENA.C.T. Total Cholesterol & PDU ActiMed Laboratories, Inc 82465QW Infopia USA LipidPro Infopia Co Ltd 82465QW Infopia USA LipidPro Professional Lipid Profile and Glucose Measuring System Infopia Co Ltd 82465QW

Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System Infopia Co, Ltd 82465QW

Lifestream Plus Cholesterol Monitor Lifestream Technologies 82465QW Lifestream Technologies Cholesterol Monitor Lifestream Technologies 82465QW Lifestream Technologies Personal Cholesterol Monitor for cholesterol Lifestream Technologies, Inc. 82465QW

Polymer Technology Systems Bioscanner, Bioscanner Plus, and Bioscanner 2000 PTS

Polymer Technology Systems, Inc 82465QW

Polymer Technology Systems MTM BioScanner 1000 Polymer Technology Systems, Inc 82465QW

Polymer Technology Systems Cardiochek Plus, Cardiochek Home Use, Home Test System, and Cardiochek PA Analyzer test strips. CardioChek Home Chol+HDL+Glu Test strips Polymer Technology Systems,

Inc

82465QW

-PTS Panels Lipid Panel test strips 82947QW -CardioChek Home Lipid Panel test strips 82947QW

Page 4: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 4 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Roche Diagnostics Accutrend Plus System WB Roche Diagnostics 82465QW Wako APOLOWAKO Analyzer Wako Chemicals USA 82465QW

Comprehensive Metabolic Panel Abaxis Piccolo Blood Chemistry Analyzer WB (Comprehensive Metabolic Reagent Disc) Abaxis, Inc 80053QW

Abaxis Piccolo xpress Chemistry Analyzer WB (Comprehensive Metabolic Reagent Disc) Abaxis, Inc 80053QW

Creatine Kinase (CK) Abaxis Piccolo Blood Chemistry Analyzer WB (Metlyte 8 Disc) Abaxis, Inc 82550QW Abaxis Piccolo xpress Chemistry Analyzer WB (Metlyte 8 Disc) Abaxis, Inc 82550QW

Creatinine Abaxis Piccolo Blood Chem Analyzer WB (Chem 6 and 13 Panels, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 82565QW

Abaxis Piccolo xpress Chem Analyzer WB (Chem 6, 13, Kidney Panels, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 82565QW

Abbott i-STAT Crea Cartridge (WB) i-STAT Corporation 82565QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82565QW Akray SPOTCHEM EX Chem Analyzer (WB) Polymedco, Inc 82565QW Siemens Clinitek 50 Urine Chemistry Analyzer (see also under Urinalysis) Bayer 82570QW

Siemens MICROABLUSTIX Reagent Strips Bayer 82570QW Siemens MultiStix PRO 10LS, PRO 11 and PRO 7G Reagent Strips (urine dipstick and urine creatinine nonautomated) Bayer 82570QW

Drugs of Abuse (Use G0477QW for visually read devices or G0478QW for instrument read devices) 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z Split Key Cup II(amphetamines, cocaine metabolites, MDMA, methamphetamines, opiates, PCP, THC)

Biosite Inc 80305QW

Abbott Diagnostics Signify ER Drug Screen Test(amphetamines, barbiturates, benzodiazepines,cocaine metabolites, MDMA, opiates, oxycodone, PCP, propoxyphene, THC, tricyclic antidepressants)

Innovacon, Inc 80305QW

Acon iCassette Multi-Drug, Multi-Line Screen Test Device (amphetamines, cocaine metabolites, methamphetamines, opiates , PCP, THC)

Acon Laboratories, Inc. 80305QW

Acon Multi-Drug, Multi-Line Screen Test Card with Integrated Cup {professional use}(amphetamines, cocaine metabolites, MDMA methamphetamines, opiates, PCP, THC)

Acon Laboratories, Inc. 80305QW

Acon On Call Multi Drug Home Test/Test Cup(amphetamines, cocaine metabolites, methamphetamines, opiates, PCP,THC) Acon Laboratories, Inc. 80305QW

Acon One Step Multi-Drug, Multi-Line Screen Test Device P{professional use}(amphetamines, cocaine metabolites, methamphetamines, opiates, PCP, THC)

Acon Laboratories, Inc. 80305QW

Acon Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device (amphetamines, cocaine metabolites, methamphetamines, opiates, PCP, THC)

Acon Laboratories, Inc. 80305QW

Accu-Stat Drugs of abuse Home Test amphetamines, cocaine metabolites, methamphetamines, opiates, PCP,THC) Accu-Stat Diagnostics, Inc. 80305QW

Page 5: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 5 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Accu-Stat Home Drug Test -Cocaine -Marijuana -Marijuana and Cocaine -Marijuana, cocaine, amphetamine, -Methamphetamine, opiates, PCP -Marijuana, cocaine, amphetamine, -Methamphetamine, opiates, ecstasy, PCP

Accu-Stat Diagnostics, Inc. 80305QW

ACCU News Drug Screening Test Card/Urine Cup (Amphetamines, Methamphetamines, Opiates, Cocaine Metabolites, Cannabinoids) Coretests, Inc 80305QW

ADC Multiple Drug Test Card (opiates, methamphetamines, cocaine metabolites, THC, PCP) Advantage Diagnostics Corp 80305QW

Accutest Multi-Drug, Multi Line Screen Test Device (amphetamines, THC, cocaine metabolites, methamphetamines. Opiates, (PCP)

Acon Laboratories, Inc. 80305QW

Advin Multi-Drug Screen Test (amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine, metabolites, EDDP, methamphetamines, morphine, methadone, opiates, oxycodone, PCP, tricyclic antidepressants, THC, MDMA)

Advin Biotech 80305QW

Aeon Multi-Drug Urine Test Cup and DipCard (amphetamines, barbituates, benzodiapzepines, buprenorphine, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants, EDDP)

Healgen Scientific Limited 80305QW

AimScreen Multi-Drug Urine Dip Card, Dip Device CLIA Waived and Test Cup (Amphetamines, Benzodiazepines, Cocaine metaboities, Cannabinoids, Methamphetamines, Oxycodone, Morphine, Barbituates, Buprenorphine, MDMA, PCP, Methadone)

Healgen Scientific Limitied 80305QW

Alatex Scientific Peace of Mind Marijuana Home Drug Test Advantage Diagnostics Corp 80305QW Alere Toxicology Service Alere iCup DxPro2 Multi-Drug Test Cup (Amphetamines, Barbiturates, Benzodiazepines, Benzodiazepines, Cocaine metabolities, Cannabinoids (THC), Methamphtamines, MDMA, Morphine, PCP, Oxycodone, Buprenorphine, Methadone, Tricyclic antidepressants)

Guanhzhou Wondfo Biotech., LTD. 80305QW

Marijuana & Cocaine Home Drug Test (OTC) Alatex Scientific 80305QW Multiple Drugs of Abuse Test Advantage Diagnostics Corp 80305QW Alere iCassette Drug Screen (amphetamines, cocaine metabolites, Methamphetamines, Opiates, PCP, THC) Biosite Inc 80305QW

Alere Toxicology Services Alere iCassette Dx Drug Screen (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, morphine, oxycodone, propoxyphene, PCP, tricyclic antidepressants, THC, MDMA)

Alere 80305QW

Alere iCUP DX Drug Screen Cup (barbiturates, amphetamines, benzodiazepines, cocaine metabolites methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants, THC)

Alere 80305QW

Alere iCUP Dx Pro Urine Drug Screening Device (amphetamines, barbiturates, , benzodiazepines, cocaine metabolites methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants, THC)

Amedica Biotech, Inc 80305QW

Page 6: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 6 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Alere iCup DX-14 Drug Screen Cassette Dip Card (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites methadone, methamphetamines, MDMA, morphine, oxycodone, propoxyphene, PCP, tricyclic antidepressants, THC)

Branan Medical Corp 80305QW

Alere iScreen DX Multi-Drug of Abuse Dip Test (barbiturates, amphetamines, benzodiazepines, buprenorphine, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants, THC)

Branan Medical Corp 80305QW

Alere iScreen DX Single Dip Card (barbiturates, amphetamines, benzodiazepines, buprenorphine, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, PCP, tricyclic antidepressants, THC)

Branan Medical Corp 80305QW

Alere Toxicology Services Drugs of Abuse Cup (amphetamines, cocaine metabolites, THC, methamphetamines, MDM A, opiates, PCP)

Alere San Diego, Inc 80305QW

Alere Tox Screen Drugs of Abuse Test Cup(amphetamines, cannabinoids, cocaine metabolites, methamphetamines, opiates, PCP, MDMA)

Alere, Inc 80305QW

Alfa Scientific Designs, Inc Confidential Drug Test-Multi Drugs of Abuse Urine (amphetamines, cocaine metabolites, morphine, THC, MDMA)

Alfa Scientific Designs, Inc 80305QW

Alfa Scientific Designs, Inc Instant View Multi Drug of Abuse Urine Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, morphine, methadone, PCP, tricyclic antidepressants, THC, MDMA)

Alfa Scientific Designs, Inc 80305QW

Alfa Scientific Designs, Inc Instant View Multi Drug of Abuse Urine Cup Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, morphine, methadone, PCP, tricyclic antidepressants, THC, MDMA)

Alfa Scientific Designs, Inc 80305QW

Alfa Scientific Designs, Inc Instant Verdict Multi Drug of Abuse Urine Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, morphine, methadone, PCP, tricyclic antidepressants, THC, MDMA)

Alfa Scientific Designs, Inc 80305QW

Alfa Scientific Designs, Inc Instant Verdict Multi Drug of Abuse Urine Cup Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, morphine, methadone, PCP, tricyclic antidepressants, THC, MDMA)

Alfa Scientific Designs, Inc 80305QW

Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cup Test (morphine, Oxycodone) Alfa Scientific Designs, Inc 80305QW

Alfa Scientific Designs, Inc. Instant-View Multi Drug of Abuse Urine Test Cup(amphetamines, barbiturates, benzodiazepines, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, opiates, PCP, tricyclic antidepressants, THC)

Alfa Scientific Designs, Inc 80305QW

Alfa Scientific Designs, Inc. Instant-View Multi Drug of Abuse Urine Test Panel(amphetamines, barbiturates, benzodiazepines, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, opiates, PCP, tricyclic antidepressants, THC)

Alfa Scientific Designs, Inc 80305QW

Alfa Scientific Designs Instant-View Drug of Abuse Urine Cassette Test (morphine, Oxycodone) Alfa Scientific Designs, Inc 80305QW

Alfa Scientific Designs, Inc Multi Drug of Abuse Urine Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, morphine, methadone, PCP, tricyclic antidepressants, THC, MDMA)

Alfa Scientific Designs, Inc 80305QW

Page 7: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 7 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Alfa Scientific Designs, Inc Multi Drug of Abuse Urine Cup Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, morphine, methadone, PCP, tricyclic antidepressants, THC, MDM

Alfa Scientific Designs, Inc 80305QW

Amedica Biotech Amedica Drug Test Cup (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, methadone, opiates, oxycodone, PCP, tricyclic antidepressants, THC, MDMA)

Amedica Biotech Inc. 80305QW

Amedica Biotech The Amedica Home Drug Test Cup (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, methadone, opiates, oxycodone, PCP, tricyclic antidepressants, THC, MDMA)

Amedica Biotech Inc. 80305QW

Amedica Biotech AmediCheck Instant Test Cup: (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, MDMA, methamphetamines, methadone, opiates, oxycodone, PCP, tricyclic antidepressants, THC)

Amedica Biotech Inc. 80305QW

Amedica Biotech Instant Test Cup (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, MDMA, methamphetamines, methadone, opiates, oxycodone, PCP, tricyclic antidepressants, THC)

Amedica Biotech Inc. 80305QW

Ameditech Inc ImmuTest Drug Screen Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

Biosite Inc 80305QW

American Bio Medica Rapid TOX (barbiturates, amphetamines, benzodiazepines, buprenorphine, cocaine metabolites, methamphetamines, methadone, opiates,, oxycodone, PCP, propoxyphene, tricyclic antidepressants, THC, MDMA)

American Bio Medica Corp 80305QW

American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, THC, methamphetamines MDMA, morphine, methadone, PCP, tricyclic antidepressants, oxycodone)

Guangzhou Wondfo Biotech Co 80305QW

American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, THC, methamphetamines MDMA, morphine, methadone, PCP, tricyclic antidepressants, oxycodone)

Guangzhou Wondfo Biotech Co 80305QW

American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, THC, methamphetamines, MDMA, morphine, opiates, PCP, oxycodone, buprenorphine)

Guangzhou Wondfo Biotech Co 80305QW

American Screening Corp Discover Drug Test Cups/Cards (amphetamines, barbiturates, benzodiazepines, buprenorphine, EDDP, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, propoxyphene, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

American Screening Corporation Discover Multi-Drug Key Cups(amphetamines, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, propoxyphene, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

Page 8: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 8 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

American Screening Corporation Discover Plus Multi-Drug Key Cups and Cards (amphetamines, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, opiates, oxycodone, PCP, propoxyphene, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

American Screening Corp Multi-Drug Test Cups/Cards (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

American Screening Corp OneScreen Drug Test Cards (amphetamines, barbiturates, benzodiazepines, buprenorphine, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, propoxyphene, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

American Screening Corp OneScreen Drug Test Cups (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

American Screening Corp Reveal Multi- Drug Testing Cups (amphetamines, barbiturates, benzodiazepines, buprenorphine, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, propoxyphene, PCP, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

American Screening Corp Reveal Mini Drug Testing Cups (amphetamines, barbiturates, benzodiazepines, buprenorphine, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, propoxyphene, PCP, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

APC Work Force solutions ZeroChaos Multi Drug Screen Cup – professional (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)

Tianjin New Bay Bioresearch 80305QW

Applied Biotech Drug Free @Home:THC (OTC) Applied Biotech, Inc 80305QW Applied Biotech Drug Free @Home:Cocaine Test (OTC) Applied Biotech, Inc 80305QW AssureTech Strip, Dip Card, Quick Cup, Turn-Key Split Cup (Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine, PCP)

AssureTech (Hangzhou) Co., Ltd. 80305QW

AssureTech Buprenorphine Strip, Panel Dip, Quick Cup, Turn Key-Split Cup AssureTech. CO.,Ltd 80305QW

AssureTech Methadone Strip, Panel Dip, Quick Cup, Turn Key-Split Cup AssureTech. CO.,Ltd 80305QW

AssureTech Oxycodone Strip, Panel Dip, Quick Cup, Turn Key-Split Cup (Barbiturates, Oxycodone) {OTC} AssureTech. CO.,Ltd 80305QW

AssureTech Secobarbital Strip, Panel Dip, Quick Cup, Turn Key-Split Cup {OTC} (Barbiturates , Oxycodone) AssureTech. CO.,Ltd 80305QW

Assured THC One step Marijuana Test Strip and Test Cassette Healgen Scientific 80305QW ATTEST (Amphetamines, Barbiturates, Benzodiapzepines, Buprenorphine, Cannabinoids, Cocaine metabolites, Methadone metabolites, Methamphetamines, MDMA, Morphine, Opiates, Oxycodone, PCP, Tricyclic antidepressants)

Advin Biotech, Inc 80305QW

Page 9: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 9 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Aventir Biotech LLC Home Check Multiple Drug Cup Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, morphine, methadone, oxycodone, PCP, tricyclic antidepressants, THC)

Tianjin New Bay Bioresearch Co 80305QW

Biotech Screening Correction Cup- Cup format ( amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methamphetamines, MDMA, morphine, oxycodone, PCP, THC, tricyclic antidepressants)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Biotech Screening Correction Cup-Cup format (amphetamines, barbiturates, benzodiazepines, cannabinoids, oxycodone)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Biotech Screening Correction Cup (cocaine metabolites, methamphetamines, MDMA, morphine, PCP, tricyclic antidepressants, methadone)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Biotech Screening, LLC, Biotech Screening Corrections Cup, Cup format (buprenorphine, amphetamines, barbiturates, benzodiazepines, cocaine metabolites, cannabinoids, MDMA, morphine, opiates, PCP, oxycodone)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Biotech Screening, LLC Corrections Cup Multi-Drug Urine Test Cup (amphetamines, buprenorphine, cannabinoids, cocaine metabolites, methadone, methamphetamines, MDMA, tricyclic antidepressants, oxycodone, morphine, benzodiazepines, PCP, barbiturates)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup (amphetamines, cocaine metabolites, THC, methamphetamines, MDMA, opiates, PCP)

Acon Laboratories, Inc. 80305QW

Biotechnostix Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device (amphetamines, cocaine metabolites, THC, methamphetamines, opiates, PCP)

Acon Laboratories, Inc. 80305QW

Branan Medical Corp Fastect II Drug Screen Dipstick Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants

Branan Medical Corporation 80305QW

Branan Medical Corp Fastect II BUP Dipcard (buprenorphine) Branan Medical Corporation 80305QW Branan Medical Corp Fastect II BUP Dipstsick (buprenorphine) Branan Medical Corporation 80305QW Branan Medical Corp FasTox Drug Dipcard (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)

Branan Medical Corporation 80305QW

Branan Medical Corp QuickTox Drug Screen (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)

Branan Medical Corporation 80305QW

Branan Medical Corp QuickTox Dipcard (buprenorphine) Branan Medical Corporation 80305QW Branan Medical Corp ToxCup Drug Screen Cup/Cassette Dip Card (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP)

Branan Medical Corporation 80305QW

BTNX Inc Know Multi-Drug One Step Screen Test Panel (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, MDMA, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

Page 10: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 10 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

BTNX Inc Rapid Response Multi-Drug One Step Screen Test Panel (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methamphetamines, morphine, MDMA, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

BTNX Inc Rapid Response Multi-Drug Urine Test Panel {Dip Card format} (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, MDMA, oxycodone, PCP, tricyclic antidepressants, buprenorphrine)

Guangzhou Wondfo Biotech Co 80305QW

BTNX Inc Rapid Response Multi-Drug Urine Test Cup{Cup format} (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, MDMA, oxycodone, PCP, tricyclic antidepressants, buprenorphines)

Guangzhou Wondfo Biotech Co 80305QW

BTNX Inc. Rapid Response Multi-Drug Urine Test Cup (Morphine 300) {cup format}(amphetamines, burenorphine, THC, cocaine metabolities, methadone, methamphetamines, MDMA, morphine, tricyclic antidepressants, benzopdiazepines, PCP, barbituates)

Guangzhou Wondo Biotech Co., Ltd 80305QW

BTNX Inc. Rapid Response Multi-Drug Urine Test Panel (Morphine 300) {Dip Card format} (oxycodone, amphetamines, buprenorphrine, THC, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, tricyclic antidepressants, benzodiazepines, PCP, barbituates)

Guangzhou Wondo Biotech Co., Ltd 80305QW

BTNX Rapid Response X-Press Drug Test Strip or Cassette (AMP/Amphetamine)(amphetamines) BTNX, Inc 80305QW

BTNX Rapid Response X-Press Drug Test (COC/Cocaine) Dip Card or Cup format (Cocaine metabolites) BTNX, Inc 80305QW

BTNX Rapid Response X-Press Drug Test(MDMA/Methylenedioxymethaphetamines) Dip Card or Cup format (MDMA)

BTNX, Inc 80305QW

BTNX Rapid Response X-Press Drug Test (MET/Methamphetamine) Dip Card or Cup format (methamphetamines)

BTNX, Inc 80305QW

BTNX Rapid Response X-Press Drug Test (MOP/Morphine) Dip Card or Cup format (morphine) BTNX, Inc 80305QW

BTNX Rapid Response X-Press Drug Test Morphine (2000) Dip Card or Cup format (Cocaine metabolites) BTNX, Inc 80305QW

BTNX Rapid Response X-Press Drug Test (MTD/Methadone) Dip Card or Cup format (methadone) BTNX, Inc 80305QW

BTNX Rapid Response X-Press Drug Test Nortriptyline Dip Card and Cup format (tricyclic antidepressants) BTNX, Inc 80305QW

BTNX Rapid Response X-Press Drug Test Oxazepam Strip or Cassette (Benzodiazepines) BTNX, Inc 80305QW

BTNX Rapid Response X-Press Drug Test (PCP/PCP) Dip Card or Cup format (PCP) BTNX, Inc 80305QW

BTNX Rapid Response X-Press Drug Test Secobarbital Strip or Cassette (Barbiturates) BTNX, Inc 80305QW

BTNX Rapid Response X-Press Drug Test Strip or Cassette (THC) BTNX, Inc 80305QW Chemtron Biotech Inc, Chemtrue Multi-Panel DOA Dip Card Tests (amphetamines, THC, cocaine meatbolites, methanphetamines, morphine, PCP,barbituates, benzodiadepines, methadone, MDMA, opiates, oxycodone, tricyclic antidepressants, buprenorphrine)

Chemtron Biotech, Inc 80305QW

Page 11: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 11 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Chemtron Biotech Inc, Chemtrue Multi-Panel DOA Dip Card with OPI 2000 Tests (amphetamines, THC, cocaine metabolites, methamphetamines, morphine, PCP, barbiturates, benzodiadepines, methadone, MDMA, opiates, oxycodone, tricyclic antidepressants, buprenorphrine)

Chemtron Biotech, Inc 80305QW

Chemtron Biotech Inc, Chemtrue Single/Multi-Panel Drug Screen Cassette Tests (benzodiazepines, barbiturates, buprenorphrine, tricyclic antidepressants, MDMA, methadone, opiates, oxycodone)

Chemtron Biotech, Inc 80305QW

Chemtron Biotech Chemtrue Single/Multi-Panel Drug Screen Cup tests: (buprenorphrine, tricyclic antidepressants, amphetamines, barbiturates, benzodiazepines, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, oxycodone, PCP, THC)

Chemtron Biotech, Inc 80305QW

Chemtron Biotech Chemtrue Screen Cup tests with OPI 2000 (buprenorphrine, tricyclic antidepressants, amphetamines, barbiturates, benzodiazepines, cocaine metabolites, MDMA, methamphetamines, methadone, opiates, oxycodone, PCP, THC)

Chemtron Biotech, Inc 80305QW

Chemtron Biotech Inc, Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests (buprenorphine, tricyclic antidepressants, amphetamines, THC, cocaine metabolites, methamphetamines, Morphine, PCP)

Chemtron Biotech, Inc 80305QW

Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests (Amphetamines, Barbiturates, Benzodiazepines, Buprenorphine, Cannabinoids, Cocaine metabolites, Methodone, Methamphetamines, MDMA, Morphine, Oxycodone, PCP, Propoxyphene, Tricyclic antidepressants)

Chemtrom Biotech, Inc. 80305QW

Chemtrue Multi-Panel Dip Card with OPI 2000 Tests (Amphetamines, Barbiturates, Benzodiazepines, Buprenorphine, Cannabinoids, Cocaine metabolites, Methodone, Methamphetamines, MDMA, Morphine, Opiates, Oxycodone, PCP, Propoxyphene, Tricyclic antidepressants)

Chemtron Biotech, Inc. 80305QW

Clarity Diagnostics LLC., Clarity CLIA Waived Multi-Drug Urine Test Cup and Test Panel (Amphetamines, Cocaine metabolites, THC, Methamphetamines, MDMA, Morphine, PCP, Oxycodone, Buprenorphine, Methadone, Tricyclic antidepressants, Benzodiazepines, Phenobarbital)

Guangzhou Wondfo Biotech Co., LTD 80305QW

Clarity Diagnostics Multi-Panel Drug Screen Dip Card Tests (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, oxycodone, PCP, THC, tricyclic antidepressants)

Chemtron Biotech, Inc 80305QW

Clarity Diagnostics Multi-Panel Drug Screen Dip Card with OPI 2000 Tests (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, MDMA, methamphetamines, methadone, opiates, oxycodone, PCP, THC, tricyclic antidepressants)

Chemtron Biotech, Inc 80305QW

CLIA Screen In-Vitro Multi-Drug Urine Test Dip Card and Test Cup (amphetamines, cocaine metabolites, barbituates, benzodiazepines, MDMA, buprenorphine, EDDP, methadone, methamphetamines, morphine, oxycodone, PCP, THC, tricycylic antidepressants)

Healgen Scientific 80305QW

Page 12: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 12 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

CLIA-X Multiple Drug Cup Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)

Tianjin New Bay Bioresearch Co 80305QW

CLIAwaived, Drug Test Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, oxycodone, PCP, tricyclic antidepressants)

Guangzhou Wondfo Biotech 80305QW

CLIAwaived, Instant Drug Test Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, oxycodone, PCP, tricyclic antidepressants)

Guangzhou Wondfo Biotech 80305QW

CLIAwaived Rapid Dip Drug Test (buprenorphine) Branan Medical Corp 80305QW CLIAwaived Rapid Drug Test Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)

Biosite, Inc / Alere 80305QW

CLIAwaived Inc. Rapid Drug Test Cup Cassette Dip Card format (amphetamines, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, oxycodone, PCP, propoxyphene, tricyclic antidepressants)

Branan Medical Corp 80305QW

CLIAwaived Rapid Drug Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP)

Branan Medical Corp 80305QW

CLIAwaived Single Drug Dipstick Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)

Branan Medical Corp 80305QW

CLIAwaived Single Drug Dipstick Test (buprenorphine) Branan Medical Corp 80305QW Clinical Reference Intelligent Transport Cup (OTC) (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)

Biosite Inc. / Alere 80305QW

Clungene Split Key Cup, Test Cup, Dip Card, Cassette (Amphetamines, Benzodiazapines, Cocaine metabolites, Methamphetamine, Morphine, Marijuana)

Hangzhou Clongene Biotech., LTD 80305QW

Coastline Medical Management Coastline Expolorer Cup (Cassette Dip Card Format) (amphetamines, barbituates, benzodiazepines, buprenorphine, THC, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, Oxycodone, PCP, proxyphene, tricyclic anitdepressants)

Branan Medical Corp 80305QW

Co-Innovation Biotech Co., Ltd Single/Multi-drug Test Cup (amphetamines, barbiturates, benzodiazepines, cocaine metaboiltes, EDDP, MDMA, methamphetamines, methadone, morphine, oxycodone, PCP, propoxyphene, THC, tricyclic antidepressants, buprenorphine)

Co-Innovation Biotech Co., Ltd 80305QW

Co-Innovation Biotech Co., Ltd Single/Multi-drug Test Dipcard (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, EDDP, MDMA, methamphetamines, methadone, morphine, oxycodone, PCP, propoxyphene, THC, tricyclic antidepressants, buprenorphine)

Co-Innovation Biotech Co., Ltd 80305QW

Page 13: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 13 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Confirm Biosciences Drugconfirm Instant Multi-Drug Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

Confirm Biosciences Reli On Multi-Drug Urine Cup Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

Confirm Biosciences Reli On Urine Screening Test (THC, cocaine metabolites, methamphetamines, morphine) Alfa Scientific Designs, Inc 80305QW

CR3 Keyless Split Sample Cup Morphine-Oxazepam-Cup System ( benzodiazepines, morphine)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

CVS/Pharmacy Inc. CVS Home Drug Test (amphetamines,barbituates, benzodiapines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)

First Check Diagnostics, LLC 80305QW

Devon Medical CentralCheck Multiple Drug Cup Test (professional use) (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)

Tianjin New Bay Bioresearch 80305QW

Diagnostic Test Group Clarity Multiple Drug Screen Cups (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

Diagnostic Test Group Clarity Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

Diagnostic Test Group Clarity Multi-Drug Test Cards (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

Diagnostic Test Group Clarity Simple Drug Screening Cups (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

Discover Plus Multi-Panel Drug Test Cups and Cards (EDDP) UCP Biosciences, Inc 80305QW Drug Detection Devices Ltd Screeners AutoCup Clinical (OTC) (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

Biosite, Inc. 80305QW

DrugSmart Multi-Panel Drug Screen Cup Tests (Amphetamines, Barbiturates, Benzodiazepines, Cocaine metabolites, MDMA, Methamphetamines, Methadone, Morphine, Oxycodone, PCP, Propoxyphene Propoxyphene, THC, Tricyclic antidepressants)

Chemtron Biotech, Inc. 80305QW

DrugSmart Multi-Panel Drug Screen Cup with OPI 2000 Test (Amphetamines, Barbiturates, Benzodiazepines, Burprenorphine, Cocanie metabolities, MDMA, Methamphetamines, Methadone, Opiates, Oxycodone, Propoxyphene, Cannabinoids, Tricyclic antidepressants, Propoxyphene)

Chemtron Biotech, Inc. 80305QW

Page 14: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 14 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Easy At Home Medical, LLC Easy@Home Multi Drug-Urine Test Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, methamphetamines, MDMA, morphine, oxycodone, PCP)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Easy At Home Medical, LLC Easy@Home Multi Drug-Urine Test Cup (methadone, tricyclic antidepressants)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Easy At Home Medical, LLC Easy@Home Multi Drug-Urine Test Panel(amphetamines, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, methamphetamines, MDMA, morphine, oxycodone, PCP)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Easy @ Home Cannabinoids Single Panel Easy at Home Medical, LLC 80305QW Easy At Home Medical, LLC Easy@Home Multi Drug-Urine Test Panel (methadone, tricyclic antidepressants)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

EGENS Biotechnology Urine Test Cup (Methamphetamine /amphetamine, and Morphine)

Nantong Egens Biotech Co., LTD. 80305QW

EGENS Biotechnology Co., Ltd,. EGENS Urine Test Marijuana (THC) Cup, DipCard, and Cassette

Nantong Egens Biotech Co., LTD. 80305QW

EGENS Biotechonology Co., Ltd,. EGENS Urine Test MDMA Cup, and DipCard

Nantong Egens Biotech Co., LTD. 80305QW

Ekla Corporation NOVAPLUS Buprenorphine Drug Test Cup S.D. Biotek, Llc 80305QW Elka Corporation NOVAPLUS Drug Test Cup(amphetamines, barbiturates, benozodiazepines, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants, THC)

S.D. Bioteck, Llc 80305QW

ELKA Corporation NOVAPLUS MDMA and OPI Drug Test Cup Urine, Cup format(MDMA, opiates)

Tianjin New Bay Bioresearch Co., Ltd 80305QW

eScreen, Inc. mCheck Multi-Line Screen Test Device: cocaine metabolites, methamphetamines, THC, opiates, PCP, amphetamines

Innovacon, Inc. 80305QW

Express Diagnostics International Inc DrugCheck Waive Drug Test Cards (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)

UCP Biosciences Inc 80305QW

Express Diagnostics DrugCheck Waive Multiple Drug Screen Cups (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

UCP Biosciences, Inc. 80305QW

Express Diagnostics DRUGCHECK Waive Drug Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)

Biosite, Inc 80305QW

Express Diagnostics DrugCheck Waive RT (Model 9380z) (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone, PCP)

Phamatech, Inc 80305QW

Express Diagnostics DrugCheck Waive TC Multiple Drug Cup Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)

Tianjin New Bay Bioresearch co 80305QW

First Check 12 Drug Cup Test(amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)

First Check Diagnostics, LLC 80305QW

Page 15: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 15 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

First Check Diagnostics LLC, Home Drug Test(amphetamines, cannabinoids, tricyclic antidepressants, cocaine metabolites, methamphetamines, opiates, PCP, barbiturates, benzodiazepines, methadone, oxycodone, MDMA

Amedica Biotech, Inc 80305QW

First Check Home Drug Test for Marijuana Acon Laboratories 80305QW First Check Multi Drug Cup (amphetamines, THC, Cocaine metabolites, MDMA, methamphetamines, opiates, PCP) Worldwide Medical, LLC 80305QW

First Check Multi Drug Cup 12 (OTC)(amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)

First Check Diagnostics, LLC 80305QW

First Sign Drug of Abuse Dip Card and Cup Test (MDMA, EDDP, Nortriptyline) W.H.P.M., INC

Forefront Diagnostics: DrugFree Home THC and COC Test Kit Forefront Diagnostics, Inc 80305QW Instacheck Drug Screen THC Applied Biotech, Inc. 80305QW Instacheck Multi-Drug Screen Panel (THC/COC) Forefront Diagnostics, Inc 80305QW Germaine Laboratories, Inc., SafeCup 14 Multi-Drug Urine test Cup (EDDP, Tricyclic antidepressants, Amphetamines, Cociane metabolites, THC, Methamphetamines, Morphine, Oxycodone, Buprenorphine, MDMA, PCP, Methadone, Benzodiazepines, Barbiturates)

Healgen Scientific 80305QW

GreenBrier Intn’l EasyScreen Marijuana Test Strip Guangzhou Wondro Biotech 80305QW Guangzhou Wondfo Biotech Co., Ltd CR3 Keyless Split Sample Cup (Amphetamines, MDMA, Methamphetamines, Cocaine metabolites, THC, Morphine, PCP, Oxycodone, Buprenorphine, Methadone, Barbiturates, Opiates)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Guangzhou Wondfo Biotech Co Ltd CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (tricyclic antidepressants, buprenorphine)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Guangzhou Wondfo Biotech Co., Ltd CR3 Keyless Split Sample Cup(MDMA, PCP) Lsi International Inc. 80305QW

Guangzhou Wondfo Biotech Co., Ltd CR3 Keyless Split Sample Cup(Morphine-Methamphetamines)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Guangzhou Wondfo Biotech Co, Ltd CR3 Keyless Split Sample Cup Oxycodone-Cannabinoids (oxycodone, THC)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Guangzhou Wondfo Biotech Co., Ltd CR3 Keyless Split Sample Cup Secobarbital-Methadone (methadone, barbituates)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Healgen Scientific LLC, Invitro Pro. Multi-Drug Urine Test DipCard (Amphetamines, Benzodiazepines, Barbiturates, Buprenorphine, Cocaine metabolites, Cannabiniods, MDMA, Methamphetamines/amphetamine, Morphine, Methadone, PCP, Oxycodone)

Healgen Scientific, Llc 80305QW

Healgen Scientific LLC, Invitro Pro. Multi-Drug Urine Test Cup (Amphetamines, Benzodiazepines, Barbiturates, Buprenorphine, Cocaine metabolites, Cannabiniods, MDMA, Methamphetamines, Morphine, Methadone, PCP, Opiates, Oxycodone)

Healgen Scientific, Llc 80305QW

Healgen Scientific LLC, Multi-Drug Urine Test Cup (Amphetamines, Benzodiazepines, Barbiturates, Buprenorphine, Cocaine metabolites, Cannabiniods, MDMA, Methamphetamines, Morphine, Methadone, PCP, Oxycodone)

Healgen Scientific, Llc 80305QW

Page 16: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 16 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Healgen Scientific LLC, Multi-Drug Urine Test Dip Card (Amphetamines, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine metabolites, THC, Methamphetamines, Morphine, Oxycodone, MDMA, PCP, Methadone)

Healgen Scientific, Llc 80305QW

Healgen Amphetamine Test Cassette Healgen Scientific, Llc 80305QW HealgenAmphetamine Test Cup Healgen Scientific, Llc 80305QW Healgen Amphetamine Test Dip Card Healgen Scientific, Llc 80305QW Healgen Amphetamine Test Strip Healgen Scientific, Llc 80305QW Healgen EDDP (Methadone Metabolite) Test Cassette Healgen Scientific, Llc 80305QW Healgen EDDP (Methadone Metabolite) Test Cup Healgen Scientific, Llc 80305QW Healgen EDDP (Methadone Metabolite) Test DipCard Healgen Scientific, Llc 80305QW Healgen EDDP (Methadone Metabolite) Test Strip Healgen Scientific, Llc 80305QW Healgen Oxazepam Test Cassette Healgen Scientific, Llc 80305QW Healgen Oxazepam Test Cup Healgen Scientific, Llc 80305QW Healgen Oxazepam Test Dip Card Healgen Scientific, Llc 80305QW Healgen Oxazepam Test Strip Healgen Scientific, Llc 80305QW Healgen Oxycodone Test Cassette Healgen Scientific, Llc 80305QW Healgen Oxycodone Test Cup Healgen Scientific, Llc 80305QW Healgen Oxycodone Test Dip Card Healgen Scientific, Llc 80305QW Healgen Oxycodone Test Strip Healgen Scientific, Llc 80305QW Healgen COC One Step CocaineTest Cassette Healgen Scientific, Llc 80305QW Healgen COC One Step Cocaine Test Cup Healgen Scientific, Llc 80305QW Healgen COC One Step Cocaine Test Dip Card Healgen Scientific, Llc 80305QW Healgen COC One Step Cocaine Test Strip Healgen Scientific, Llc 80305QW Healgen THC One Step Marijuana Test Cassette Healgen Scientific, Llc 80305QW Healgen THC One Step Marijuana Test Cup Healgen Scientific, Llc 80305QW Healgen THC One Step Marijuana Test Dip Card Healgen Scientific, Llc 80305QW Healgen THC One Step Marijuana Test Strip Healgen Scientific, Llc 80305QW Healgen mAMP One Step Methamphetamine Test Cassette Healgen Scientific, Llc 80305QW Healgen mAMP One Step Methamphetamine Test Cup Healgen Scientific, Llc 80305QW Healgen mAMP One Step Methamphetamine Test Dip Card Healgen Scientific, Llc 80305QW Healgen mAMP One Step Methamphetamines Test Strip Healgen Scientific, Llc 80305QW Healgen Methadone Test Cassette Healgen Scientific, Llc 80305QW Healgen Methadone Test Cup Healgen Scientific, Llc 80305QW Healgen Methadone Test Dip Card Healgen Scientific, Llc 80305QW Healgen Methadone Test Strip Healgen Scientific, Llc 80305QW Healgen MOP One Step MorphineTest Cassette Healgen Scientific, Llc 80305QW Healgen MOP One Step MorphineTest Cup Healgen Scientific, Llc 80305QW Healgen MOP One Step Morphine Test Dip Card Healgen Scientific, Llc 80305QW Healgen MOP One Step Morphine Test Strip Healgen Scientific, Llc 80305QW Healgen Morphine Test Cassette Healgen Scientific, Llc 80305QW Healgen Morphine Test Cup Healgen Scientific, Llc 80305QW Healgen Morphine Test Dip Card Healgen Scientific, Llc 80305QW Healgen Morphine Test Strip Healgen Scientific, Llc 80305QW Healgen MDMA Test Cassette LSI International Inc. 80305QW Healgen MDMA Test Cup LSI International Inc. 80305QW Healgen MDMA Test Dip Card LSI International Inc. 80305QW Healgen MDMA Test Strip LSI International Inc. 80305QW Healgen Multi-Drug Urine Test Cup and Dip Card (EDDP, Tricyclic anti-depressants) Healgen Scientific LLC 80305QW

Healgen Nortriptyline Test Cassette (Tricyclic Anitdepressants) Healgen Scientific, Llc 80305QW Healgen Nortriptyline Test Cup (Tricyclic Anitdepressants) Healgen Scientific, Llc 80305QW

Page 17: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 17 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Healgen Nortriptyline Test Dip Card (Tricyclic Anitdepressants) Healgen Scientific, Llc 80305QW Healgen Nortriptyline Test Strip (Tricyclic Anitdepressants) Healgen Scientific, Llc 80305QW Healgen Buprenorphine Test Cassette Healgen Scientific, Llc 80305QW Healgen Buprenorphine Test Cup Healgen Scientific, Llc 80305QW Healgen Buprenorphine Test Dip Card Healgen Scientific, Llc 80305QW Healgen Buprenorphine Test Strip Healgen Scientific, Llc 80305QW Healgen PCP Test Cassette LSI International Inc. 80305QW Healgen PCP Test Cup LSI International Inc. 80305QW Healgen PCP Test Dip Card LSI International Inc. 80305QW Healgen PCP Test Strip LSI International Inc. 80305QW Healgen Propoxyphene Test Cassette Healgen Scientific, Llc 80305QW Healgen Propoxyphene Test Dip Card Healgen Scientific, Llc 80305QW Healgen Propoxyphene Test Cup Healgen Scientific, Llc 80305QW Healgen Propoxyphene Test Strip Healgen Scientific, Llc 80305QW Healgen Secobarbital Test Cassette Healgen Scientific, Llc 80305QW

Healgen Secobarbital Test Dip Card Healgen Scientific, Llc 80305QW Healgen Secobarbital Test Cup Healgen Scientific, Llc 80305QW Healgen Secobarbital Test Strip Healgen Scientific, Llc 80305QW Indentifi Biosciences, Inc., Identifi Multi-Panel (Amphetamines, Barbituates, Benzodiazepines, Cocaines metabolites, Methadone, Methamphetamines, MDMA, Morphine, Oxycodone, Opiates, PCP, Ticyclic Anit-depressants, THC, Buprenophines, Propoxyphene, EDDP)

UCP Biosciences, Inc

80305QW

IND Home Amphetamine Test (strip format) IND Diagnostic, Inc 80305QW IND Home Amphetamine, Marijuana, Cocaine, Methamphetamines, Morphine Test (cassette format) IND Diagnostic, Inc 80305QW

IND Home Cocaine and Methamphetamines Test (strip format) IND Diagnostic, Inc 80305QW IND Home Marijuana Test (strip format) IND Diagnostic, Inc 80305QW IND Home Drug Test Multi-Panel Strip and lCassette Formats (amphetamines, cocaine metabolites, methamphetamines, morphine, THC)

IND Diagnostic, Inc 80305QW

Innovacon Integrated E-Z Split Key Cup II (amphetamines cocaine metabolites, THC, methamphetamines, MDMA, opiates, PCP)

Innovacon 80305QW

Innovacon Multi-Clin Drug Screen Test Device (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, MDMA, morphine, oxycodone, PCP, propoxyphene, tricyclic antidepressants)

Innovacon, Inc 80305QW

Insight Medical Drug of Abuse Cassette/Cup (morphine, oxycodone) Alfa Scientific Designs, Inc 80305QW

Insight Medical Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

Insta-Screen Multi-Drug Urine Dip Card (amphetamines, benzodiazepines, THC, cocaine metabolities, methamphetamines, morphine, oxycodone, barbituates, buprenorphine, methadone, MDMA, PCP, EDDP tricycic antidepressants)

Healgen Scientif Limited 80305QW

Instant Technologies iCassette Dx Drug Screen Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, MDMA, opiates, oxycodone, PCP, propoxyphene, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

Page 18: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 18 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Instant Technologies iCup Dx Drug Screen Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone,, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

Instant Technologies iScreen Drug of Abuse Cassette and Cup (morphine, oxycodone) Alfa Scientific Designs, Inc 80305QW

Instant Technologies iScreen Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

Instant-View Multi-Drug Urine Test Cup and Panel (Home Use) (amphetamines, barbituates, benzodiazepines, buprenorphine, THC, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, opiates, PCP, tricylic antidepressants)

Alfa Scientific Designs, Inc. 80305QW

Intrinsic Interventions, Inc., VistaFlow (Amphetamines, Barbiturates, Benzodiazepines, THC, Cocaine Metabolites, Methadone, Methamphetamines, MDMA, Morphine, Opiates, Oxycodone, PCP, Tricyclic antidepressants, Propoxyphene, Buprenorphine, EDDP)

Advin Biotech, Inc. 80305QW

iTest, iCassette for marijuana, cocaine, amphetamine, methamphetamine, opiates, PCP Accu-Stat Diagnostics, Inc. 80305QW

iTest, iCup for marijuana, cocaine, amphetamine, methamphetamine, ecstasy, opiates, PCP Accu-Stat Diagnostics, Inc. 80305QW

Inverness Med Innovations Signify ER Drug Screen(amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, MDMA, opiates, oxycodone, PCP, propoxyphene, tricyclic antidepressants)

Biosite, Inc 80305QW

Jant Pharmacal Accutest Buprenorphine Drug Test Cup Tianjin New Bay Bioresearch Co 80305QW

Jant Pharmacal Accutest Drug Test Cup (MDMA and opiates) Tianjin New Bay Bioresearch Co 80305QW

Jant Parmacal AccutestDrug of Abuse Cassette and Cup (morphine, oxycodone) Alfa Scientific Designs Inc 80305QW

Jant Pharmacal Accutest Drug Test Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, MDMA, methadone, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

Amedicda Biotech, Inc 80305QW

Jant Pharmacal Accutest Drug Test Cup (professional use) (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)

Tianjin New Bay Bioresearch 80305QW

Jant Pharmacal Accutest MultiDrug ER11 Drug Screen (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, MDMA, opiates, oxycodone, PCP, propoxyphene, tricyclic antidepressants)

Innovacon, Inc 80305QW

Jant Pharmacal Accutest Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, PCP, tricyclic antidepressants)

Alfa Scientific Designs Inc 80305QW

Jant Pharmacal Accutest Multi-Drug Urine Test Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, THC, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, opiates, PCP, tricyclic antidepressants)

Guangzhou Wondofu Biotech CO.,LTD. 80305QW

Page 19: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 19 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Jant Pharmacal Accutest Multi X Drug Cup Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)

Tianjin New Bay Bioresearch 80305QW

Jant Pharmacal Accutest SplitCup: (amphetamines, THC, cocaine metabolites, methamphetamines, MDMA, opiates, PCP) Innovacon, Inc 80305QW

Jant Pharmaceutical Corporation Accutest Propoxyphene Urine Test and Urine Test Cup Wondfo Biotech Co., LTD. 80305QW

Kasaac Laboratories Drug Test(amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, methamphetamines, oxycodone, PCP, tricyclic antidepressants, cannabinoids, opiates)

Tianjin New Bay Bioresearch Co., Ltd 80305QW

Kasaac Laboratories, Inc Kasaac Laboratories Buprenorphine Drug Test (opiates)

Tianjin New Bay Bioresearch Co., Ltd 80305QW

Kasaac Laboratories Multi (MDMA ands OPI) Drug Test Cup Urine, Cup format(MDMA, opiates)

Tianjin New Bay Bioresearch Co., Ltd 80305QW

LifeSign Home Drug Tests:Marijuana, Cocaine Metabolites Princeton Biomeditech Corp 80305QW LifeSign Home Drug Tests:Marijuana, Opiates, Cocaine Metabolites, and Methamphetamines Princeton Biomeditech Corp 80305QW

MedDirect Inc ProXam Drug Test Cards(amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)

UCP Biosceinces, Inc 80305QW

MedDirect Inc Multiple Drug Screen Cups(amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)

UCP Biosceinces, Inc 80305QW

Medical Distribution Group Inc., Identify Diagnostics Home Drug Test Cards and Cups (Buprenorphine, Amphetamines, Cocaine metabolites, EDDP Methamphetamines, MDMA, Oxycodone, Opiates, Morphine, PCP, THC, Benzodiazepines, Methadone, Barbiturates, Tricyclic antidepressants, Propoxyphene)

UCP Biosceinces, Inc 80305QW

Medical Distribution Group Inc., Identify Diagnostics Drug Test Cards and Cups (EDDP) UCP Biosciences, Inc 80305QW

Medimpex Q Test Buprenorphine Drug Cup Test (opiates) Tianjin New Bay Bioresearch Co 80305QW

Medimpex Q Test Multi X Drug Cup Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)

Tianjin New Bay Bioresearch Co 80305QW

Micro Distributing II Ltd Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

Micro Distributing II Ltd STAT Cup3 One Step Drug Test Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, THC)

Guangzhou Wondfo Biotech 80305QW

Micro Distributing II Ltd STATDIP One Step Multi-Drug Urine Test Panel (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, THC)

Guangzhou Wondfo Biotech 80305QW

Page 20: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 20 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Micro Distributing II Ltd STAT Cup One Step Drug Test Dip Care/Cup (amphetamines, barbiturates, benzodiazepines, THC, oxycodone)

Guangzhou Wondfo Biotech 80305QW

Millennium Laboratories INSTA-SCREEN Multi-Drug Urine Test Cup (amphetamines, buprenorphine, cannabinoids, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, tricyclic antidepressants, benzodiadepines, PCP, barbiturates, oxycodone)

Guangzhou Wondo Biotech Co., Ltd 80305QW

Millennium Laboratories INSTA-SCREEN Multi-Drug Urine Test Panel (amphetamines, buprenorphine, cannabinoids, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, tricyclic antidepressants, benzodiadepines, PCP, barbiturates, oxycodone)

Guangzhou Wondo Biotech Co., Ltd 80305QW

Millennium Lab Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

Millennium Lab Multi-Drug Pain Med Screen Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

Biosite, Inc 80305QW

MP Biomedical MP On-site Buprenorphine Drug of Abuse Test Cup

Tianjin New Bay Bioresearch Co., Ltd 80305QW

MP Biomedical, LLC MP-On-Site Drugs of Abuse Test Cup (amphetamines, PCP, methamphetamines, morphine, cocaine metabolites, barbiturates, benzodiazepines, cannabinoids, methadone, oxycodone, tricyclic antidepressants)

Tianjin New Bay Bioresearch Co., Ltd 80305QW

Native Diagnostics International, DrugSmart Drug Screen Cup Tests (amphetamines, barbituates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, oxycodone, PCP, tricyclic antidepressants)

Chemtron Biotech, Inc 80305QW

Native Diagnostics International, DrugSmart Drug Screen Cup Tests with OPI 2000 (amphetamines, barbituates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, opiates oxycodone, PCP, tricyclic antidepressants)

Chemtron Biotech, Inc 80305QW

Native Diagnostics International, DrugSmart Dip Single/Multi-Panel Drug Screen Cassette Tests(amphetamines, cannabinoids, cocaine metabolites, methamphetamines, morphine, PCP, barbituates,benzodiazepines,methadone,MDMA, opiates,oxycodone)

Chemtron Biotech, Inc 80305QW

Native Diagnostics International, DrugSmart Dip Single/Multi- Panel Drug Screen Dip Card Tests(amphetamines, cannabinoids, cocaine metabolites, methamphetamines, morphine, PCP, buprenorphine, tricyclic antidpressants,barbituates,benzodiazepines,methadone, MDMA, opiates,oxycodone) )

Chemtron Biotech, Inc 80305QW

Native Diagnostics International DrugSmart Dip Multi-Panel Drug Screen Dip Card Tests (buprenorphine, tricyclic antidepressants, amphetamines, barbituates, benzodiazepines, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, oxycodone, PCP, THC)

Chemtron Biotech, Inc 80305QW

Page 21: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 21 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Native Diagnostics International DrugSmart Dip Multi-Panel Drug Screen Dip Card with OPI 2000 Tests (Buprenorphine, tricyclic antidepressants, amphetamines, barbituates, benzodiazepines, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, opiates,oxycodone, PCP, THC)

Chemtron Biotech, Inc 80305QW

Native Diagnostics International, DrugSmart Dip Single/Multi-Panel Drug Screen Cassette Tests (barbiturates, benzodiazepines, methadone, MDMA, opiates, oxycodone)

Chemtron Biotech, Inc 80305QW

Native Diagnostics International, DrugSmart Dip Single/Multi-Panel Drug Screen Dip Card Tests (barbiturates, benzodiazepines, methadone, MDMA, opiates, oxycodone)

Chemtron Biotech, Inc 80305QW

NexScreen LLC, NexScreen Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

Amedica Biotech, Inc 80305QW

NexScreen Multi-Drug Test Cup and Dip Card (amphetamines, benzodiazepines, THC, cocaine metabolites, methamphetamines, morphine, oxycodone, barbituates, buprenorphine, methadone, MDMA, PCP, EDDP, tricyclic antidepressants)

Healgen Scientific 80305QW

Noble Medical Inc NOBLE1 Step Cup (OTC) (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

Biosite / Alere 80305QW

Noble Medical Inc. Noble 1 Step + Cup (Buprenorphine, Morphine, Propoxyphene, Amphetamines, Barbiturates, Benzpdiazepines, THC, Cocaine metabolites, Methamphetamines, Methadone, MDMA, Oxycodone, PCP, Tricyclic antidepressants)

Branan Medical Corp. 80305QW

Noble Medical, Inc INSTA-SCREEN Multi-Drug Urine Test Cup (oxycodone)

Guangzhou Wondo Biotech Co., Ltd 80305QW

Noble Medical, Inc INSTA-SCREEN Multi-Drug Urine Test Cup(amphetamines, buprenorphine, cannabinoids, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, tricyclic antidepressants, benzodiazepines, PCP, barbiturates, oxycodone)

Guangzhou Wondo Biotech Co., Ltd 80305QW

Noble Medical, Inc INSTA-SCREEN Multi-Drug Urine Test Panel (oxycodone)

Guangzhou Wondo Biotech Co., Ltd 80305QW

Noble Medical, Inc INSTA-SCREEN Multi-Drug Urine Test Panel (amphetamines, buprenorphine, cannabinoids, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, tricyclic antidepressants, benzodiazepines, PCP, barbiturates, oxycodone)

Guangzhou Wondo Biotech Co., Ltd 80305QW

Noble Medical Inc INSTA-SCREEN Multi-Drug Urine Test Cup (cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, PCP, tricyclic antidepressants)

Guangzhou Wondfo Biotech 80305QW

Noble Medical Inc INSTA-SCREEN Multi-Drug Urine Test Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, THC)

Guangzhou Wondfo Biotech 80305QW

Noble Medical Inc., INSTA-SCREEN Multi-Drug Test Cup II (Amphetamines, Cocaine metabolites, EDDP, Tricyclic antidepressants, THC, Methamphetamines, Morphine, Oxycodone, Buprenorphine, MDMA, PCP, Methadone, Benzodiazepines, Barbiturates)

Healgen Scientifc Limited 80305QW

Page 22: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 22 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Nobel Medical Split-Specimen Cup (amphetamines, THC, cocaine metabolites, methamphetamines, MDMA, opiates, PCP) Nobel Medical 80305QW

On the Spot Drug Testing Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

On-Site Testing Specialists Inc. On-Site Testing Specialist Multi-Panel Drug Screen Cup and Dip Card Tests (amphetamines, barbituates, benzodiapines, buprenorphine, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, oxycodone, PCP, propoxyphene, THC, tricyclic antidepressants)

Chemtron Biotech, Inc. 80305QW

On-Site Testing Specialists Inc. On-Site Testing Specialist Multi-Panel Drug Screen Cup and Dip Card with OPI2000 Tests (amphetamines, barbituates, benzodiapines, buprenorphine, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, oxycodone, opiates, PCP, propoxyphene, THC, tricyclic antidepressants)

Chemtron Biotech, Inc 80305QW

On-Site Testing Specialists Inc. On-Site Testing Specialist Drug Screen Cup Tests (amphetamines, barbituates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, MDMA, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)

Chemtron Biotech, Inc. 80305QW

On-Site Testing Specialists Inc. On-Site Testing Specialist Drug Screen Cup Tests with OPI 2000 (amphetamines, barbituates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, MDMA, methadone, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)

Chemtron Biotech, Inc. 80305QW

On-Site Testing Specialists Inc. On-Site Testing Specialist Single/Multi-Panel Drug Screen Dip Card Tests (amphetamines, barbituates, benzodiazepines, buprenorphine, cocaine metabolites, MDMA, methadone, methamphetamines, morphine, oxycodone, PCP, THC, tricyclic antidepressants)

Chemtron Biotech, Inc 80305QW

On-Site Testing Specialists Inc. On-Site Testing Specialist Single/Multi-Panel Drug Screen Dip Card with OPI 2000 Tests (amphetamines, barbiturates, benzodiazepines, buprenorphone, cocaine metabolites, methadone, methamphetamines, opaites, oxycodone, PCP, THC, Tricyclic antidepressants, MDMA)

Chemtron Biotech, Inc 80305QW

Phamatech At Home Drug Test Model: -9063/9063T (Amphetamine) -9064 (amphetamines) -9068/9068T (Methamphetamines) -9069 (methamphetamines) -9073/9073T (Cocaine Metabolites) -9074 (cocaine metabolites) -9078/9078T (THC) -9079 (THC) -9083/9083T (Opiates) -9084 (opiates) -9133/9133T (PCP) -9150/9150T (THC, Opiates, Cocaine Metabolites, Methamphetamine, Amphetamine) -9175 (Methamphetamines, THC) and Opiates)

Phamatech, Inc. 80305QW

Page 23: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 23 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Phamatech QuickScreen At Home Drug Test Model: -9171 (Methamphetamines and Opiates) -9150 (Amphetamines, Cocaine Metabolites, Methamphetamines, Opiates, PCP and THC)

Phamatech, Inc 80305QW

Phamatech QuickScreen At Home 12 Drug Test Models 9308Z and 9308T(amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, MDMA, methamphetamines, oxycodone, opiates, PCP, THC)

Phamatech, Inc 80305QW

Phamatech QuickScreen One Step (amphetamines, cocaine metabolites, methamphetamines, opiates, PCP) Phamatech, Inc 80305QW

Phamatech QuickScreen One Srep Amphetamines Screening Test Phamatech, Inc 80305QW Phamatech QuickScreen One Srep Cocaine Screening Test Phamatech, Inc 80305QW Phamatech Quick Screen One Srep Methamphetamine Screening Test Phamatech, Inc 80305QW

Phamatech Quick Screen One Srep Opiate Screening Test Phamatech, Inc 80305QW Phamatech Quick Screen One Srep PCP Screening Test Phamatech, Inc 80305QW Phamatech Quick Screen One Srep THC Screening Test Phamatech, Inc 80305QW Phamatech QuickScreen Pro Multi Drug Screening Test (Model 9177/ and 9178) Methamphetamine, THC, PCP, amphetamine, cocaine and opiates

Phamatech, Inc 80305QW

Phamatech QuickScreen Model 9177X (amphetamines, cocaine metabolites, opiates, PCP,THC) Phamatech, Inc 80305QW

Phamatech Quickscreen Model 9178X (amphetamines, cocaine metabolites, opiates, methamphetamines, THC) Phamatech, Inc 80305QW

PharmTox Rapid Exam Drug Screen Test Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

Amedica Biotech, Ind 80305QW

Physicians’ Test Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

Polymed Therapeutic FaStep Marijuana Strip Polymed Therapeutics, Inc 80305QW Polymed Therapeutic FaStep Marijuana Panel Dip Polymed Therapeutics, Inc 80305QW Polymed Therapeutic FaStep Marijuana Quick Cup Polymed Therapeutics, Inc 80305QW Polymed Therapeutic FaStep Marijuana Turn-Key Split Cup Polymed Therapeutics, Inc 80305QW Polymed Therapeutic FaStep Methamphetamine Strip Polymed Therapeutics, Inc 80305QW Polymed Therapeutic FaStep Methamphetamine Panel Dip Polymed Therapeutics, Inc 80305QW Polymed Therapeutic FaStep Methamphetamine Quick Cup Polymed Therapeutics, Inc 80305QW Polymed Therapeutic FaStep Methamphetamine Turn-Key Split Cup Polymed Therapeutics, Inc 80305QW

Polymed Therapeutics FaStep Panel Dip, Turn-Split Cup (Amphetamines, Cocaine metabolites, Morphine, Phencyclidine) Polymed Therapeutics, Inc 80305QW

Polymed Therapeutics FaStep Strip (Amphetamine, Barbiturates, Buprenorphine, Cocaine metabolities, Methadone, Morphine, Oxycodone, Phencyclidine)

Polymed Therapeutics, Inc 80305QW

Polymed Therapeutics FaStep Barbiturates/Oxycodone Panel Dip (Barbiturates, Oxycodone) Polymed Therapeutics, Inc 80305QW

Polymed Therapuetics FaStep Barbiturates/Oxycodone Quick Cup and Turn Ket Split Cup (Barbiturates, Oxycodone) Polymed Therapeutics, Inc 80305QW

Polymed Therapeutics FaStep Buprenorphine/Methadone Panel Dip and Quick Cup (Buprenorphine, Methadone) Polymed Therapeutics, Inc 80305QW

Page 24: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 24 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Polymed Therapeutics FaStep Buprenorphine/Methadone Turn-Key Split Cup (Buprenorphine, Methadone) Polymed Therapeutics, Inc 80305QW

Polymed Therapeutics FaStep Marijuana Panel Dip 50 Polymed Therapeutics, Inc 80305QW Polymed Therapeutics FaStep Marijuana Quick Cup 50 Polymed Therapeutics, Inc 80305QW Polymed Therapeutics FaStep Marijuana Turn-Key Split Cup 50 Polymed Therapeutics, Inc 80305QW Polymed Therapeutics FaStep Methamphetamine Panel Dip 1000 Polymed Therapeutics, Inc 80305QW Polymed Therapeutics FaStep Methamphetamine Quick Cup 1000 Polymed Therapeutics, Inc 80305QW Polymed Therapeutics FaStep Methamphetamine Rapid Test Strip Polymed Therapeutics, Inc 80305QW Polymed Therapeutics FaStep Methamphtamine Turn-Key Split Cup 1000 Polymed Therapeutics, Inc 80305QW

Polymed Therapeutics FaStep Rapid Test Strip (Cannabinoids, Methamphetamine) Polymed Therapeutics, Inc 80305QW

Premier Biotech, Inc., MDETOX Multi-Drug Urine Test Cup and Dip Card (Amphetamines, Benzodiazepines, Cocaine Metabolites, THC, Methamphetamines, Morphine, Oxycodone, Barbiturates, Buprenorphine, PCP, Methdone, EDDP, MDMA, Tricyclic antidepressants)

Healgen Scientific 80305QW

Premier BioTech Premier Bio-Cup & Bio-Dip (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, THC, MDMA, methadone, EDDP, morphine, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

Advin Biotech, Inc. 80305QW

Premier Integrity Solutions P/Tox Drug Screen Cup (OTC) amphetamines, barbiturates, benzodiazepines, cocaine metabolites, THC, MDMA, methadone, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants

Biosite Inc / Alere 80305QW

Princeton Biomeditech -Accusign Stik THC -Accusign THC -Accustik THC -Accustrip THC -Lifesign Home Drug Test Marijuana -Status DS THC -Status Stik THC

Princeton Biomeditech

80305QW

PTox Drug Screen Cup-Cassette Dip Card Format (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, Oxycodone, PCP, propoxyphene, THC, tricyclic antidepressants

Branan Medical Corp 80305QW

Quest Products DrugHAWK Home Drug Test Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, THC, MDMA, methadone, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

Amedica Biotech 80305QW

Quest Products DrugHAWK Home Drug Test Cup (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, THC, tricyclic antidepressants)

Tianjin New Bay Bioresearch Co., Ltd. 80305QW

Quest Products, Inc. DrugHAWK MDMA and OPI Drug Test cup (urine) {Cup format} (MDMA, opiates)

Tianjin New Bay Bioresearch Co., Ltd. 80305QW

Quest Diagnostics Express Results Integrated Multi-Drug Screen Cup (amphetamines, cocaine metabolites, THC, MDMA, methamphetamines, opiates, PCP)

Innovacon, Ind 80305QW

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DOH 681-018 April 2017 Page 25 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

QuikTest USA Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)

Alfa Scientific Designs 80305QW

RediScreen Multi-Drug, Multi-Line Screen Test Device (amphetamines, THC, cocaine metabolites, methamphetamines, opiates, PCP)

Acon Laboratories, Inc. 80305QW

Redwood Toxicology Laboratory Reditest 6 Cassette Substance Abuse Screening Device: Cocaine metabolites, THC, Methamphetamines, Opiates, PCP, Amphetamines

Innovacon, Inc. 80305QW

Redwood Toxicology Laboratory Reditest Freedom Cup (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, THC, MDMA, methadone, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

Biosite, Inc. 80305QW

Redwood Toxicology Laboratory Reditest Home Drug Test (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, THC, MDMA, methadone, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

Biosite, Inc. 80305QW

Revolution Diagnostics, AccuSeal Pro Instant Test Cup (MDMA)(Opiates) Tianjin New Bay Bioresearch 80305QW

Revolution Dx AccuSeal Pro Instant Test Cup Test (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, THC, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)

Tianjin New Bay Bioresearch 80305QW

Revolution Dx AccuSeal Pro Instant Test Cup Test Buprenorphine Tianjin New Bay Bioresearch 80305QW Safecare Urine Test Cassette, Cup, Dip Card (Amphetamine, Cocaine metabolites, Marijuana)

Safecare Biotech (Hangzhou)Co.,LTD. 80305QW

SafeCup II Multi-Drug Urine Test Cup (EDDP, Tricyclic antidepressants, amphetamines, cocaine metabolites, THC, methamphetamines, morphine, oxycodone, buprenorphine, MDMA, PCP, methodone, benzodiazepines, barbituates)

Healgen Scientific 80305QW

Screen Tox Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

SCI International New Choice At Home Drug Test (marijuana) strip format Ind Diagnostic Inc 80305QW

SDBiotek ForSure Buprenorphine Drug Cup Test (opiates) Tianjin New Bay Bioresearch 80305QW Statics Stik (THC, OP, COC, Ecstasy, Met) Princeton Biomeditech Corp 80305QW Syntron Bioresearch Quickscreen Buprenorphine Drug Cup (opiates) Tianjin New Bay Bioresearch 80305QW

Syntron Bioresearch Inc. Quikscreen Multi MDMA Drug Cup Test (MDMA, Opiates) Tianjin New Bay Bioresearch 80305QW

Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) (amphetamines, THC, Cocaine metabolites, methamphetamines, PCP, Tricyclic antidepressants, oxycodone, morphine, methadone, benzodiazepines, barbiturates)

Tianjin New Bay Bioresearch 80305QW

Tanner Scientific Inc., BluRapids Multi-Drug Urine Test Panel and Test Cup (amphetamines, THC, Cocaine metabolites, methamphetamines, PCP, Tricyclic antidepressants, opiates, MDMA, morphine, methadone, benzodiazepines, buprenorphine, barbiturates)

Guangzhou Wondfo Biotech Co., LTD. 80305QW

Page 26: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 26 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Tanner Scientific Multi-Panel Drug Test Cup (Amphetamines, Barbituates, Benozodiapines, Buprenorphone, Cannabinoids, Cocaine Metabolites, EDDP, Methadone, Methamphetamines, MDMA, Morphone, Oxycodone, PCP, Propoxyphene, Tricyclic anitdepressants)

Co-Innovation Biotech Co., Ltd 80305QW

Tanner Scientific Inc., Platinum Line Multi-Panel Drug Test Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, propoxyphene, THC, tricyclic antidepressants)

UCP Biosciense, Inc 80305QW

TeenSavers Diag Teen Savers Home Drug Test (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone, PCP, THC, tricyclic antidepressants)

Amedica Biotech, Inc 80305QW

Total Diagnostic Solutions Drug of Abuse Cassette/Cup (morphine, oxycodone) Alfa Scientific Designs, Inc 80305QW

Total Diagnostic Solutions Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, THC, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

Toxi-Cup MDMA and OPI (Opiates) Urine Drug Test Tianjin New Bay Bioresearch Co., Ltd. 80305QW

Toxi-Cup Urine Drug Test Cup (Amphetamines, Buprenophine, Methamphetamines, Oxycodone, PCP, THC, Benzodiazepines, Cocaine metabolites, Barbiturates, Morphine, Methadone, Tricyclic antidepressants)

Tianjin New Bay Bioresearch Co., Ltd. 80305QW

Transmetron Invitro Pro Drug Test Cups (amphetamines, barbiturates, benzodiazepines, buprenorphine, THC, cocaine metabolites, methampetamine, methadone, MDMA morphine,opiates, oxycodone, PCP, propoxyphene,tricyclic antidepressants)

Transmetron 80305QW

Transmetron, Inc. Invitro Pro Drug Test Cards (amphetamines, barbiturates, benzodiazepines, buprenorphine, THC, cocaine metabolites, methampetamine, methadone, MDMA morphine,opiates, oxycodone, PCP, propoxyphene,tricyclic antidepressants)

UCP Biosciences 80305QW

Twin Spirit Inc DrugSmart Cup (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, MDMA, methamphetamines, oxycodone, opiates, PCP, THC, tricyclic antidepressants)

Amedica Biotech Inc 80305QW

UCP Biosciences, Inc., u-Card and u-Cup Drug Test Screen (Amphetamines, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine Metabolities, MDMA, Opiates, Methamphetamines, Morphine, PCP, THC, Methadone, Tricyclic Antidepressants, Oxycodone, Propoxyphene, EDDP )

UCP Biosciences, Inc 80305QW

UCP Biosciences, UCP Compact Drug Test Cards and Cups (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, methadone, MDMA. methamphetamines, morphine, oxycodone, opiates, PCP, propoxyphene, THC, tricyclic antidepressants)

UCP Biosciences 80305QW

Page 27: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 27 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

UCP Biosciences, UCP Multi-Drug Test Key Cups (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, methadone, MDMA. methamphetamines, oxycodone, opiates, PCP, propoxyphene, THC, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

UCP Biosciences, UCP Drug Test Mini Cups (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, methadone, MDMA. methamphetamines, oxycodone, opiates, PCP, propoxyphene, THC, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

UCP Biosciences, Inc., U-Card Drug Test Cards and Test Cups (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, methadone, MDMA. methamphetamines, morphine, oxycodone, opiates, PCP, propoxyphene, THC, tricyclic antidepressants

UCP Biosciences, Inc 80305QW

UCP Biosciences U-Checker Drug screening Test Cups (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, MDMA. methamphetamines, morphine, oxycodone, opiates, PCP, THC, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

UCP Biosciences UPC Compact Drug Test Cups/Cards (buprenorphine, propoxyphene) UCP Biosciences, Inc 80305QW

UCP Biosciences UCP Drug screening Test Cups (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, MDMA. methamphetamines, morphine, oxycodone, opiates, PCP, THC, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

UCP Compact Drug Test Card/Cup Urine (EDDP) UCP Biosciences, Inc 80305QW UCP Drug Screening Test Cards/Cups (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, MDMA. methamphetamines, morphine, oxycodone, opiates, PCP, THC, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

UCP Home Drug Screening Test Cards/Cups (buprenorphine, propoxyphene) UCP Biosciences, Inc 80305QW

UCP Multiple Drug Screen Cups (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, methadone, MDMA. methamphetamines, morphine, oxycodone, opiates, propoxyphene, PCP, THC, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

Ultimate Analysis Cup UA Cups (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, methadone, MDMA. methamphetamines, morphine, oxycodone, opiates, PCP, propoxyphene, THC, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

Ultimate Analysis Cup UA Cups Test Cards (amphetamines, barbiturates, benzodiazepines, buprenorphine cocaine metabolites, methadone, MDMA. methamphetamines, morphine, oxycodone, opiates, PCP, propoxyphene, THC, tricyclic antidepressants)

UCP Biosciences, Inc 80305QW

US Diagnostics ProScreen Drugs of Abuse Cup (OTC) (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)

Biosite Inc / Alere 80305QW

US Diagnostics UScreen Drugs of Abuse Card/Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, THC, cocaine metabolites, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)

Guangzhou Wondfo Biotech 80305QW

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DOH 681-018 April 2017 Page 28 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

US Diagnostics UScreen Drugs of Abuse Dip Card/Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, THC, methadone, methamphetamines, MDMA, morphine, opiates, oxycodone, PCP, tricylic antidepressants)

Guangzhou Wondfo Biotech 80305QW

US Diagnostics UScreenDrugs of Abuse Dip Card/Cup (cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, PCP, tricyclic antidepressants)

Guangzhou Wondfo Biotech 80305QW

uVera Diagnostics ,Inc. CR3 Keyless Split Sample Cup (Amphetamines, Barbituates, Cocaine Metabolites, Benzodiazepines, THC, Methamphetamines, MDMA, Morphine, PCP, Oxycodone, Burenorphine, Methadone, Tricyclic Anitdepressants)

Guangzhou Wondfo Biotech 80305QW

uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup (opiates, buprenorphine) Guangzhou Wondfo Biotech 80305QW

uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup (opiates, buprenorphine) Guangzhou Wondfo Biotech 80305QW

uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup (opiates, buprenorphine) Guangzhou Wondfo Biotech 80305QW

uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup (opiates, buprenorphine) Guangzhou Wondfo Biotech 80305QW

Wal-mart Stores, Inc, ReliOn Home Drug Urine Cup Test (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, MDMA methadone, methamphetamines, morphine, oxycodone PCP, THC, tricyclic antidepressants)

Alfa Scientific Designs, Inc 80305QW

WayPoint Biomedical Health Essist Multi-Drug Test Cup (amphetamines, TCH, cocaine metabolites, methamphetamine/amphetamine, opiates, PCP, MDMA)

Innovacon, Inc. 80305QW

WHPM Inc, First Sign Drug of Abuse Cup Test(amphetamines, cannabinoids, cocaine metabolites, methadone, methamphetamines, opiates, oxycodone, PCP, benzodiazepines, buprenorphine, butalbital, morphine)

W.H.P.M., Inc 80305QW

WHPM Inc, First Sign Drug of Abuse Dip Card Test Test(amphetamines, cannabinoids, cocaine metabolites, methadone, methamphetamines, opiates, oxycodone, PCP, benzodiazepines, morphine)

W.H.P.M., Inc 80305QW

Wolfe Drug Testing RealityCheck Integrated Specimen Cup (amphetamines, cocaine metabolites, methamphetamines, MDMA, opiates, PCP, THC)

Innovacon, Inc. 80305QW

Wondfo Amphetamine Urine Test (Cup & DipCard (AMP 500) Guangzhou Wondfo Biotech 80305QW Wondfo Amphetamine, Secobarbital, Oxazepam Urine Test (Cup & Dip Card) Guangzhou Wondfo Biotech 80305QW

Wondfo Buprenorphine Urine Test Cup/Dip Card Guangzhou Wondfo Biotech 80305QW Wondfo THC Urine Test (Cup & Dip Card) Guangzhou Wondfo Biotech 80305QW Wondfo Cocaine Urine Test (Cup & Dip Card) (COC 150) Guangzhou Wondfo Biotech 80305QW Wondfo MDMA Urine Test (Cup & Dip Card) Guangzhou Wondfo Biotech 80305QW Wondfo Methadone Urine Test (Cup & Dip Card) Guangzhou Wondfo Biotech 80305QW Wondfo Methamphetamines Urine(Cup & Dip Card) (MET 500) Guangzhou Wondfo Biotech 80305QW Wondfo Morphine Urine Test (Cup & Dip Card) Guangzhou Wondfo Biotech 80305QW Wondo Nortriptyline Urine Test (Cup & Dip Card) Guangzhou Wondfo Biotech 80305QW Wondfo Oxycodone Urine Test (Cup & Dip Card) Guangzhou Wondfo Biotech 80305QW Wondfo PCP Urine Test (Cup & Dip Card) Guangzhou Wondfo Biotech 80305QW Wondfo Propoxyphene (Cup & Dip Card) Guangzhou Wondfo Biotech 80305QW

Page 29: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 29 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Wondfo Multi-Drug Urine Test (Cup/Dipcard) (cocaine metabolites, methadone, MDMA. methamphetamines, morphine, PCP, tricyclic antidepressants)

Guangzhou Wondfo Biotech 80305QW

Wondfo Multi-Drug Urine Test (Cup/Dipcard) (amphetamines, barbiturates, benzodiazepines, oxycodone, THC, ) Guangzhou Wondfo Biotech 80305QW

Wondfo Multi-Drug Urine Test (Cup/Dipcard) (Buprenorphine) Guangzhou Wondfo Biotech 80305QW Wondfo Multi-Drug Urine Test (Cup/Dipcard) (amphetamine, , benzodiazepines, barbiturates, buprenorphine cocaine metabolites, MDMA methadone, methamphetamines, morphine, PCP THC, tricyclic antidepressants)

Guangzhou Wondfo Biotech 80305QW

Wondfo Biotech Co., Ltd., Wondofo Propoxyphene Urine Test Cup and DipCard Guangzhou Wondfo Biotech 80305QW

Wondfo USA Co., Ltd One Step Saliva Alcohol Test Strip Ethanol (alcohol) TECO Diagnostics 80305QW

Wondfo USA Co., Ltd CLIA Screen Multi-Drug Urine Test Cup (methadone, tricyclic antidepressants)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Wondfo USA Co., Ltd CLIA Screen Multi-Drug Urine Test Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine , cocaine metabolites, methamphetamines, MDMA, morphine, oxycodone, PCP, cannabinoids)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Wondfo USA Co., Ltd CLIA Screen Multi-Drug Urine Test Cup (methadone, tricyclic antidepressants)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Wondfo USA Co., Ltd CLIA Screen Multi-Drug Urine Test Panel (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, methamphetamines, MDMA, morphine, oxycodone, PCP, buprenorphine)

Guangzhou Wondfo Biotech Co., Ltd 80305QW

Worldwide Medical Corporation First Check Home Drug Test (amphetamines) Worldwide Medical Corporation 80305QW

Worldwide Medical Corporation, First Check Home Drug Test Panel 3 (THC-COC-Met) Worldwide Medical Corporation 80305QW

Worldwide Medical Corporation, First Check Home Drug Test (THC-COC) Worldwide Medical Corporation 80305QW

Worldwide Medical Corporation, First Check Home Drug Test (THC) Worldwide Medical Corporation 80305QW

Worldwide Medical Corporation, First Check Home Drug Test Panel 4 (THC-COC-OPI-MET) Worldwide Medical Corporation 80305QW

Worldwide Medical First Check Multi Drug Cup 7 OTC (Amphetamines, THC, Cocaine Metabolites, Methamphetamines, MDMA, Opiates, PCP

Worldwide Medical Corporation 80305QW

Wunder Test Home Drug Screen (Marijuana) Hien Nguyen 80305QW Electrolyte Panel

Abaxis Piccolo Blood Chemistry Analyzer WB (Electrolyte Reagent Disc) Abaxis, Inc 80051QW

Abaxis Piccolo xpress Chemistry Analyzer WB (Electrolyte Reagent Disc) Abaxis, Inc 80051QW

Erythrocyte Sedimentation Rate (ESR) (nonautomated) Various 85651

Esterone-3-Glucuronide Unipath Limited Clearplan Easy Fertility Monitor Unipath, Inc. 82679QW

Ethanol Acon Lab Mission Saliva Alcohol Test Strip Acon Laboratories, Inc 82055QW Alere Toxicology iScreen Saliva Alcohol Test Strip Acon Laboratories, Inc 82055QW

Page 30: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 30 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Alfa Scientific Designs Oral-View Saliva Alcohol Test Strip Acon Laboratories, Inc 82055QW American Screening Reveal Saliva Alcohol Test Acon Laboratories, Inc 82055QW Chematics Inc. Alco-Screen Saliva Alcohol Chematics, Inc. 82055QW Chematics Inc. Alco-Screen 02 Saliva Alcohol Chematics, Inc 82055QW CLIAwaived Rapid Saliva Alcohol Test Acon Laboratories, Inc 82055QW Express Diagnostics International, Incorporated Saliva Alcohol Test Teco Diagnostics 82055QW

Germaine Laboratories Aim Strip Alcohol Saliva Acon Laboratories, Inc 82055QW Jant Pharmacal Corp Accustrip Saliva Alcohol Test Strip Acon Laboratories, Inc 82055QW OraSure Technologies Q.E.D. A-150 Saliva Alcohol Test OraSure Technologies 82055QW OraSure Technologies Q.E.D. A-350 Saliva Alcohol Test OraSure Technologies 82055QW STC Q.E.D. A-150 Saliva Alcohol Test OraSure Technologies 82055QW STC Q.E.D. A-350 Saliva Alcohol Test OraSure Technologies 82055QW Teco Diagnostics Saliva Alcohol Test Teco Diagnostics 82055QW

Fern Test (Saliva for Ovulation) – See Ovulation

Follicle Stimulating Hormone (FSH) Acon Laboratories FSH Menopause Predictor Test Acon Laboratories, Inc. 83001QW Acon Laboratories FSH One Step Menopause Test Strip/Device Acon Laboratories, Inc. 83001QW Applied Biotech Menopause Predictor Test (FSH) Applied Biotech, Inc. 83001QW Applied Biotech Instacheck FSH Test (Professional) Applied Biotech, Inc. 83001QW Applied Biotech RU25 Plus FSH Menopause Test Applied Biotech, Inc. 83001QW Biotechnostix Rapid Response FSH One Step Menopause Test Device Acon Laboratories, Inc. 83001QW

BTNS Rapid Response FSH Menopausal Test Ind Diagnostics, Inc. 83001QW Genosis Fertell Female Fertility Test (FSH) Genosis, Inc. 83001QW Genua Menopause Monitor Test), Qualitative Genua 1944, Inc. 83001QW IND Diagnostic, Inc. One Step FSH Menopausal Test (midstream) IND Diagnostic, Inc. 83001QW IND Diagnostic, Inc. One Step Strip Style FSH Menopausal Test (professional use) IND Diagnostic, Inc. 83001QW

IND Diagnostic, Inc. One Step FSH Menopausal Test (Strip/Cassette) IND Diagnostic, Inc. 83001QW

IND Diagnostic, Inc. One Step Cassette Style FSH Menopausal Test (professional use) IND Diagnostic, Inc. 83001QW

Pan Probe Biotech Early Detect Menopause Test FSH Early Detect, Inc. 83001QW Phamatech Moments Menopause Check (FSH) Phamatech 83001QW QuantRx Biomedical QuantRx Female Fertility Test Quantrx Biomedical Corp 83001QW RAC Medical Clarity FSH One Step Menopause Test Device (professional use) Acon Laboratories, Inc. 83001QW

Synova Healthcare Menocheck Menopause Indicator Test/Menocheckpro (professional use) Applied Biotech, Inc. 83001QW

Fructosamine

LNX Fructosamine Test System LXN Corporation 82985QW

LXN Duet Glucose Monitoring System (for fructosamine and glucose [see below] LXN Corporation 82985QW

LXN IN CHARGE Diabetes Control System (glucose monitoring device [see below] & fructosamine) LXN Corporation 82985QW

Gamma Glutamyl Transferase (GGT) Abaxis Piccolo Blood Chemistry Analyzer WB (Chem 6, Chem 13 Abaxis, Inc. 82977QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) Abaxis, Inc. 82977QW

Page 31: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 31 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Abaxis Piccolo xpress Chemistry Analyzer WB (Chem 6, Chem 13, Liver) Abaxis, Inc. 82977QW

Glucose Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use Various 82962

Abaxis Piccolo Blood Chem Analyzer WB(Chem 6, Chem 13, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 82947QW

Abaxis Piccolo Point Of Care Chemistry Analyzer (Lipid Panel Reagent Disc) Glucose Abaxis, Inc. 82947QW

Abaxis Piccolo xpress Chem Analyzer WB (Chem 6, Chem 13, CMP, BMP, Lipid Panel Plus, Metlyte 8, Renal) Abaxis, Inc. 82947QW

Abbott i-STAT G Cartridge (WB) i-STAT Corporation 82947QW Abbott i-STAT 4+ Cartridge (WB) i-STAT Corporation 82947QW Abbott i-STAT 6+ Cartridge (WB) i-STAT Corporation 82947QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82947QW Accuchek Instant Plus dual Testing System Roche Diagnostics 82962 Alere Cholestech LDX (glucose)(WB) Alere, Inc 82947QW Arkray SPOTCHEM EZ Chemistry Analyzer (WB) Arkray, Inc. 82947QW Biomedix Inc Q Steps Biometer G/C Dual Monitoring System Biomedix, Inc. 82962 Cholestech LDX (Software version 1.40 or above) Cholestech 82947QW -Post glucose dose 82950QW -GTT 3 spec 82951QW -GTT ea additional sample >3 samples 82952QWea Cygnus Inc. GlucoWatch Automatic Glucose Biographer Cygnus, Inc Pending Diagnostic Test Group, Clarity Blood Glucose Monitoring System Taidoc Technology Corporation 82947QW HemoCue B-Glucose Photometer

HemoCue

82947QW -Post glucose dose 82950QW -GTT 3 spec 82951QW -GTT ea additional sample >3 samples 82952QWea HemoCue Glucose 201 Micro cuvettes and Glucose 201 Analyzer/201DM

HemoCue

82947QW

-Post glucose dose 82950QW -GTT 3 spec 82951QW -GTT ea additional sample >3 samples 82952QWea Jant Pharmacal Lipid Plus Lipid Profile and Glucose Measuring System Infopia Co, Ltd 82465QW

LXN Duet Glucose Monitoring System (for fructosamine [see above] and glucose) LXN Corporation 82962

LXN IN CHARGE Diabetes Control System (glucose monitoring device & fructosamine [see above]) LXN Corporation 82962

Nova Biomedical StatStrip Glucose Hospital Meter System Nova Biomedical Corporation Pending Polymer Technology Systems Cardiochek PA Analyzer PTS (prescription use)

Polymer Technology Systems, Inc. 82962

Polymer Technology Systems Cardiochek Plus, Cardiochek Home Use and Cardiochek PA Analyzer test strips

Polymer Technology Systems, Inc.

82947QW Polymer Technology Systems, Inc., CardioChek Home Test System (CardioChek eGLU test strips, CaridoChek Home Chol+HDL+Glu Test strips) -PTS Panels Glucose and eGLU test strips -Post glucose dose 82950QW -GTT 3 spec 82951QW

Page 32: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 32 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

-GTT ea additional sample >3 samples 82952QW ea

StatStrip Xpress Blood Glucose Montoring System Nova Biomedial Corporation Pending Wako APOLOWAKO Analyzer (WB) Wako Chemicals USA

82947QW -Post glucose dose 82950QW -GTT 3 spec 82951QA

-GTT ea addition sample >3 samples 82952QW ea

Glycosylated HGB Alere Technologies AS, Alere Afinion AS100 Analyzer Axis-Shield Pos As 83036QW Axis-Shield Afinion AS100 Analyzer (HbA1C) Axis-Shield Pos As 83036QW Bayer A1C Now Self check Bayer Healthcare, LLC 83037QW Bayer A1C Now+ (professional use) Bayer Healthcare, LLC 83036QW Bio-Rad Micromat II Hemoglobin A1C Prescription Home Use Bio-Rad 83037QW BIO-RAD in2it(II) System Analyzer Prescription Home Use Bio-Rad Laboratories, Inc 83037QW Bristol-Myers Squibb, Co. Choice DM Bristol-Myers Squibb, Co 83036QW

Chek Diagnostics A1C Now SelfCheck Polymer Technology Systems, Inc 83036QW

Chek Diagnostics A1C Now+ Professional Use Polymer Technology Systems, Inc 83036QW

Cholestech GDX A1C Test (Prescription Home Use) (hemoglobin A1C)[7-1-02] Cholestech Corporation 83037QW

MEC Dynamics Avie A1c Test System MEC Dynamics Corp 83036QW Metrika DRx HbA1C for glycosylated hemoglobin Metrika, Inc. 83036QW Metrika InView Multi-Test A1C Monitor Metrika, Inc. 83036QW Metrika A1c Now (Glycosylated hemoglobin, total) Metrika, Inc. 83036QW Provalis Diagnostics Glycosal HbA1c Provalis Diagnostics Ltd. 83037QW Provalis Diagnostics G5 Glycosal I HbA1c Provalis Diagnostics Ltd. 83036QW Provalis Diagnostics G5 Glycosal II HbA1c Provalis Diagnostics Ltd. 83036QW Provalis Diagnostics In2it In-Office Analyzer (II) A1C prescription home use test system Provalis Diagnostics Ltd 83037QW

PTS Diagnostics A1CNow + Professional Use Polymer Technology Systems, Inc

83036QW

PTS Diagnostics A1Cnow Self Check D/B/A PTS Diagnostics 83037QW

Siemens DCA 2000 Analyzer Siemens Healthcare Diagnostics 83036QW

Siemens DCA 2000+ Analyzer Siemens Healthcare Diagnostics 83036QW

Siemens Medical Diagnostics DCA Vantage Analyzer Siemens Medical Solutions Diagnostics 83036QW

Wako APOLOWAKO Analyzer (WB) Wako Chemicals USA Inc 83036QW HDL Cholesterol

Abaxis Piccolo xpress Chemistry Analyzer {capillary-finger stick} (HDL cholesterol) Abaxis, Inc. 83718QW

Abaxis Piccolo xpress Chemistry Analyzer WB (Lipid Panel/Lipid Panel Plus) Abaxis, Inc 83718QW

Abaxis Piccolo Point of Care Chemistry Analyzer WB (Lipid Panel/Lipid Panel Plus) Abaxis, Inc 83718QW

Accutech CholesTrak HDL Cholesterol Home Test AccuTech, LLC 83718QW Alere Cholestech LDX (HDL)(WB) Alere, Inc 83718QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 83718QW Cholestech LDX (Must have software version 1.40 or above) Cholestech 83718QW

Page 33: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 33 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Infopia USA LipidPro Infopia Co Ltd 83718QW Infopia USA LipidPro Professional Lipid Profile and Glucose Measuring System Infopia Co Ltd 82465QW

Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System Infopia Co, Ltd 83718QW

Polymer Technology Systems BioScanner, BioScanner Plus, Bioscanner 2000 for HDL Cholesterol

Polymer Technology Systems, Inc. 83718QW

Polymer Technology Systems Cardiochek Plus, Cardiochek Home Use and Cardiochek PA Analyzer test strips

-PTS Panels Lipid Panel test strips -CardioChek Home Lipid Panel test strips

Polymer Technology Systems, Inc. 83718QW

Polymer Technology Systems, Inc., CardioChek PA Home Test System (CardioChek Home Lipid Panel test strips, CaridoChek Home Chol+HDL+Glu test strips)

Polymer Technology Systems, Inc. 83718QW

Helicobacter Pylori Abbott FlexPack HP Test for whole blood Abbott Laboratories 86318QW Abbott Signify H. pylori (whole blood) Abbott Laboratories 86318QW Abbott Signify H. pylori Cassette (whole blood) Abbott Laboratories 86318QW Abbott TestPack Plus H. pylori (for whole blood) Abbott Laboratories 86318QW Acon Helicobacter pylori Rapid Test Device (WB) Acon Laboratories 86318QW Alere Clearview H.pylori Whole Blood Only Alere San Deigo, Inc 86318QW Alere Signify H.pylori Whole Blood Only Alere San Deigo, Inc 86318QW Alfa Sci. Designs Instant View H. pylori (WB) Alfa Scientific Designs, Inc. 86318QW Applied Biotech SureStep H. pylori WB test (WB) Applied Biotech 86318QW ARJ Pylo-Plus Urease Test (gastric biopsy tissue) ARJ Medical, Inc 87077QW Ballard Medical Products (Delta West) CLOtest for H. pylori in gastric biopsy tissue Ballard Medical Products 87077QW

Beckman Coulter Primary Care Diagnostics Flexsure H. pylori (whole blood) Beckman Coulter, Inc. 86318QW

Becton Dickinson LINK 2 H. pylori Rapid Test (for whole blood) Same as Boehringer Mannheim AccuStat H. pylori OneStep Becton Dickinson 86318QW

BTNX Inc Rapid Response H. pylori Rapid Test Device (WB) BTNX Inc. / Innovacon 86318QW Cardinal Hlth SP Brand Rapid Test H. pylori (WB) Applied Biotech, Inc. 86318QW ChemTrak AccuMeter H. pylori test for WB ChemTrak 86318QW CLIAwaived H. pylori Whole Blood Rapid Test Alfa Scientific Designs, Inc. 86318QW Clarity H. pylori Rapid Test Device (WB) Innovacon 86318QW De Healthcare Prod Truview H. pylori Test (WB) Applied Biotech, Inc. 86318QW Diagnostic Test Group Clarity H. pylori Rapid Test Device (WB) Princeton Biomeditech Corp 86318QW EarlyDetect H. pylori Whole Blood Rapid Test Alfa Scientific Designs Inc 86318QW Fisher Healthcare Sure-Vue H. pylori Test (WB) Innovacon 86318QW Germaine Laboratories AimStep H. pylori (WB) Acon Laboratories, Inc. 86318QW Germaine Laboratories AimStep H. pylori (WB) Princeton Biomeditech Corp. 86318QW GI Supply Div. Chek-Med Systems HP One (H. pylori in gastric biopsy tissue)

GI Supply Div. Chek-Med Systems 87077QW

GI Supply HP-FAST for H. pylori in gastric biopsy Mycoscience Labs, Inc. 87077QW Henry Schein OneStep+ H. pylori (whole blood) Applied Biotech, Inc. 86318QW Immunostics Detector H. pylori (WB) Princeton Biomeditech Corp 83618QW Instant Tech. iScreen H. pylori Rapid Test Device Acon Laboratories, Inc 86318QW Inverness BTNX Inc Rapid Response H. pylori (wb) Acon Laboratories, Inc 86318QW Inverness Medical Clearview H. pylori Test (WB) Innovacon, Inc. 86318QW Inverness Medical SIGNIFY H. pylori whole blood Innovacon, Inc. 86318QW JANT Accutest Rapid Urease test (H.pylori detection) ARJ Medical, Inc. Pending

Page 34: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 34 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Jant Parmacal Accutest H. pylori rapid Test Device (WB) Innovacon 86318QW Jant Parmacal H. pylori WB Test Applied Biotech, Inc. 86318QW LifeSign H. pylori WB (for whole blood) Princeton BioMeditech Corp 86318QW LifeSign Status H. pylori (for WB) Princeton BioMeditech 86318QW McKesson H. pylori Test (WB) (Cassette) Alere 86318QW McKesson Medi-Lab Performance H. pylori (WB) Innovacon 86318WQ Med Inst.CorpPronto Dry H. pylori (gastric biopsy) Medical Instruments Corp 87077QW Medline H. pylori Test Cassette (whole blood) Alere 87077QW Merid. Biosci. ImmunoCard STAT! H.pylori (WB) Meridian Bioscience 86318QW Merid. Biosci. ImmunoCard STAT! HpSA (stool) Meridian Bioscience 87899QW Polymedco, Inc. Poly stat H. pylori (WB) Applied Biotech, Inc. 86318QW PreMaxim RadiScreen H. pylori (WB) Acon Laboratories, Inc 86318QW Princeton BioMeditech BioSign H.pylori WB Princeton BioMeditech Corp 86318QW Princeton BioMeditech BioSign H.pylori WB (OSOM H. pylori) {serum, plasma, whole blood} Princeton BioMeditech Corp 86318QW

Pro-Advantage by NDC H. pylori Device WB Innovacon, Inc 86318QW PSS Consult H. pylori Cassette WB finger stick only Alere 86318QA Quidel QuickVue H.pylori (WB) Quidel 86318QA Quidel QuickVue H. pylori gII Test (WB) Quidel 86318QW Quidel QuickVue One-Step H. pylori test for (WB) Quidel 86318QW Quidel QuickVue One-Step H. pylori II test (WB) Quidel 86318QW Remel RIM A.R.C. H. pylori Test (WB) Remel 86318QW Roche Diagnostics AccuStat H. pylori OneStep (WB) Roche Diagnostics 86318QW Select Medical Products Brand Rapid Test H. pylori Innovacon 86318QW Serim Pyloritek Test Kit for Helicobacter pylori in gastric biopsy tissue Serim 87077QW

Serim Pyloritek VP Test Kit (H.pylori) (WB) Serim Research Corporation 87077QW SmithKline FlexSure HP test for IgG antibodies to H. pylori in whole blood SmithKline Diagnostics, Inc. 86318QW

Stanbio RELY H.pylori Rapid Test (WB finger stick only) Alere 86318QW Trinity Uni-Gold H. pylori (whole blood) Trinity BioTech, PLC 86318QW Wampole Laboratories Clearview H. pylori II (WB) Applied Biotech, Inc. 86318QW

Hematocrit Abbott i-STAT 3+ Cartridge (WB) i-STAT Corporation 85014QW Abbott i-STAT 4+ Cartridge (WB) i-STAT Corporation 85014QW Abbott i-STAT 6+ Cartridge (WB) i-STAT Corporation 85014QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 85014QW Microhematocrit (spun) Various 85013 Micro Diag. Spuncrit DRC-40 Infrared Analyzer Micro Diagnostics Spuncrit 85014QW UltraCrit Separation Technology, Inc 85014QW Wampole STAT-CRIT Wampole 85014QW

Hemoglobin Abbott i-STAT 3+ Cartridge (WB) i-STAT Corporation 85017QW Abbott i-STAT 4+ Cartridge (WB) i-STAT Corporation 85017QW Abbott i-STAT 6+ Cartridge (WB) i-STAT Corporation 85017QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 85017QW Aim Strip Hb Hemoglobin (Hb) Testing System Acon Laboratories, Inc. 85018QW Alere HemoPoint HX System Stanbio Laboratory 85018QW Alere HemoPoint H2 Hemoglobin Measurement Sys Stanbio Laboratory 85071QW Avie Total HbTest System (professional use) Mee Dynamics Corp 85018QW Biosafe Laboratory’s Anemiapro Self Screener Biosafe Laboratory 85018QW

Page 35: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 35 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Biotest Hemoglobin Measuring System Biotest 85018QW Clarity HbCheck Hemoglobin Testing System Acon Laboratories, Inc. 85018QW CLIAwaived Inc. Hemoglobin (Hb) Testing System CLIAwaived Inc. 85018QW Copper-sulfate (non-automated) Various 83026 Diaspect Hemoglobin Measuring System Diaspect Medical GMBH 85018QW EKF Diagnostic Hemo_Contol Measurement and Hemo_Control Microcuvettes EKF Diagnostic GMBH Pending

Hemocue Donor Hemoglobin Checker System Hemocue 85018QW Hemocue Hemoglobin System HemoCue 85018QW Hemocue Hemoglobin 201+/Hemocue Hemoglobin Microcuvette System Hemocue 85018QW

HemoCue Hb 201 DM Analyzing System Hemocue 85018QW HemoCue Hb 301 System Hemocue 85018QW GDS Diagnostics HemoSite Meter for Hgb GDS Diagnostics 85018QW GDS Technology STAT-Site M Hgb Test System (hemoglobin) GDS Technology 85018QW ITC HGB PRO Prof. Hemoglobin Testing System ITC 85018QW Mission Plus Hemoglobin (Hb) Testing System Acon Laboratories, Inc. 85018QW Stanbio Hemoglobin Analyzer Stanbio 85018QW Stanbio HemoPoint H2 Hemoglobin Measurement System Stanbio 85018QW Stanbio HemoPoint H2 DM Hemoglobin Measurement System (with data management) Stanbio 85018QW

Hepatitis C Virus Antibody OraQuick HCV Rapid Antibody Test and Oraquick HCV Visual Reference Panel Orasure Technologies 86803QW

Herpes Theranos anti-HSV-1 IgG Assay (Fingerstick Whole Blood Only) Theranos, Inc Pending

HIV Alere Determine HIV-1/2 Ag/Ab Combo Fingerstick Whole Blood) Orgenics, LTD. 87806QW bioLytical INSTI HIV-1 Antibody Test (finger stick WB) bioLytical Laboratories, Inc 86701QW Chembio Diagnostic Systems, Inc, DPP HIV ½ Assay (Oral Fluid, Fingerstick WB, Venipuncture WB)

Chembio Diagnostic Systems, Inc 86703QW

Chembio HIV ½ STAT-PAK Assay (finger stick & venipuncture WB)

Chembio Diagnostic Systems, Inc 86703QW

Chembio DPP HIV ½ Assay (oral fluid) Chembio Diagnostic Systems, Inc G0433QW

Clearview COMPLETE HIV 1 / 2 (finger stick & venipuncture WB Chembio Diagnostic Systems, Inc 86703QW

Orgenics, Alere Determine HIV-1/2 Ag/Ab Combo (Fingerstick Whole Blood) Orgenics, Ltd. 87806QW

Oraquick Advance Rapid HIV-1/2 Antibody Test (oral fluid, finger stick & venipuncture WB) OraSure Technologies, Inc 86703QW

OraQuick In-Home HIV Test (oral fluid) Orasure Technologies, Inc 86703QW Oraquick Rapid HIV-1 Antibody Test (HIV-1 antibodies) (finger stick & venipuncture WB) OraSure Technologies, Inc 86701QW

Trinity Biotech Uni-Gold Recombigen HIV Test (finger stick and venipuncture whole blood)

Trinity Biotech Manufacturing Limited 86701QW

Influenza Alere BinaxNOW Influenza A & B Card (nasopharyngeal, nasal wash/aspirate) Alere Scarborough, Inc 87804QA

Alere Influenza A & B Test (Nasal Swab only) Alere Scarborough, Inc 87502QW Alere I Influenza A & B Test (Direct Nasal Swab only) Alere Scarborough, Inc 87502QW

Page 36: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 36 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Alere Scarborough Inc. Medline Influenza A & B Test Alere Scarborough, Inc 87804QA BD Veritor System, Rapid Flu A+B (nasal, nasopharyngeal) (also version with reader) Becton Dickinson and Co 87804QW

Binax NOW Flu A Test (Influenza A) Binax, Inc. 87804QW Binax NOW Flu B Test (Influenza B) Binax, Inc. 87804QW Binax NOW Influenza A&B Test (NP/nasal wash, nasal swabs) Binax, Inc. 87804QW BioSign Flu A+B test (nasal, nasopharyngeal) Princeton Biomeditech Corp. 87804QW BTNX Rapid Response Influenza A Test Cassette Sa Scientific Inc 87804QW BTNX Rapid Response Influenza B Test Cassette Sa Scientific Inc 87804QW Cepheid Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) Cepheid 87807QW

Clearview Exact II Influenza A & B (Nasal swabs only) Inverness Medical 87804QW Cobas Infulenza A/B Nucleic Acid Test for Use on the cobas Liat System IQUUM, INC 87804QW

EarlyDetect Pro Influenza A Test SA Scientific Inc 87804QW EarlyDetect Pro Influenza B Test SA Scientific Inc 87804QW Henry Schein OneStep+Influenza A&B Test Binax Inc 87804QW

LifeSign LLC, Status Flu A+B Princeton BioMeditech Corporation 87804QW

Medline Industries, Inc. Meidline Influenza A &B Test Alere Scarborough, Inc D/B/A Binax, Inc. 87804QW

Quidel QuickVue Influenza Test [Influenza A/B] Quidel Corporation 87804QW Quidel QuickVue Influenza A+B Test Quidel Corporation 87804QW Roche Molecular, cobas Liat System (cobas Liat Influenza A/B Assay) Iquum, Inc Pending

SA Scientific SAS Influenza A SA Scientific, Inc. 87804QW SA Scientific SAS Influenza B SA Scientific, Inc. 87804QW Sekisui Diagnostics LLC, OSOM Ultra Flu A Influence A/B 87804QW Sofia Analyzer & Influenza A+B FIA (nasal) Quidel Corp. 87804QW ZymeTX Zstatflu Test (Influenza A/B) ZymeTX, Inc. 87449QW

Ketones (Blood) Abbott Freestyle precision pro glucose and beta-ketone monitoring system Abbott Diabetes Care 82010QW

Abbott Laboratories, Medisense Precision Xtra Advanced Diabetes Management System (ketone) Abbott Laboratories 82010QW

Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System (ketone) Abbott Diabetes Care Ind 82010QW

Nova Max Mini Glucose and B-Ketone Monitoring Nova Biomedical 82010QW Nova Max Plus Glucose and B-Ketone Monitoring Nova Biomedical 82010QW Polymer Technology Systems BioScanner/BioScaner PTS for Blood Ketones

Polymer Technology Systems, Inc. 82010QW

Lactic Acid KDK Corp Lactate Pro System OTC (Lactic Acid) KDK Corporation 83605QW

LDL Cholesterol

Polymer Technology Systems Cardiochek/Cardiochek PA Analyzer Polymer Technology System 83721QW

Lead ESA Biosciences LeadCare II Blood Lead Testing System (whole blood) ESA Biosciences, Inc. 83655QW

Lipid Profile (Cholesterol, HDL Cholesterol and Triglycerides)

Page 37: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 37 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Abaxis Piccolo Point of Care Chemistry Analyzer (Lipid Panel Reagent Disc)(WB) Piccolo 80061QW

Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 80061QW Cholestech LDX (Software version 1.40 or above) Cholestech 80061QW Infopia USA LipidPro Lipid Profile Test Strips Infopia Co Ltd 80061QW Infopia USA LipidPro Professional Lipid Profile and Glucose Measuring System Infopia Co Ltd 82465QW

Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System Infopia Co, Ltd 80061QW

Jant Pharmacal Lipid Plus Lipid Profile and Glucose Measuring System(LipidPro Lipid Profile test strips) Infopia Co, Ltd 80061QW

Jant Pharmacal Corp,LipidPlus Professional Lipid Profile and Glucose Measuring System Infopia Co, Ltd 80061QW

Jant Pharmacal Corp,LipidPlus Professional Lipid Profile and Glucose Measuring System(LipidPlus Lipid Profile test strips) Infopia Co, Ltd 80061QW

Jant Pharmacal LipidPlus lipid profile and glucose measuring system Infopia Co., Ltd 80061QW

Jant Pharmacal LipidPlus lipid profile and glucose measuring system(LipidPro Lipid Profile test strips) Infopia Co., Ltd 80061QW

Polymer Technology System, Inc., CardioChek Plus Test System (PTS Panels Lipid Panel test strips)

Polymer Technology Systems, Inc 80061QW

Polymer Technology Systems Bioscanner Plus (PTS Panels Lipid Panel Test Strips)

Polymer Technology Systems, Inc 80061QW

Polymer Technology Systems Cardiocheck and Cardiochek PA Analyzers (PTS Panels Lipid Panel Test Strips)

Polymer Technology Systems, Inc 80061QW

Polymer Technology Systems, Inc., CardioChek Home Test System (CardioChek Home Lipid Panel test strips)

Polymer Technology Systems, Inc 80061QW

Lithium Akers Laboratory Inc InstaRead Lithium System (finger stick or venipuncture whole blood) Akers Laboratories, Inc. 80178QW

ReliaLAB, Inc. InstaRead Lithium System (finger stick or venipuncture whole blood) Akers Laboratories, Inc. 80178QW

Luteinizing Hormone (LH) (see ovulation tests) BTNX Inc Rapid Response LH Ovulation Test Ind Diagnostic Inc Pending

Chembio Sure Check Ovulation Predictor Chembio Diagnostic Systems, Inc 83002QW

Invernexx Medical Early Ovulation Predictor Stix Selfcare, Inc. 83002QW Saless Enterprises New Choice Ovulation Predictor (Cassette, Midstream) Ind Diagnostic Inc 83002QW

Unipath Limited Clearplan Easy Fertility Monitor Unipath, Ltd 83002QW Lyme Disease

Wampole PreVue B. burgdorferi Antibody for Lyme Disease Antibodies Wampole 86618QW

Matrix Metalloproteinases-9 (MMP-9) Rapid Pathogen Screening, Inc. InflammaDry Rapid Pathogen Screening, Inc. 83516QW

Microalbumin Micral Chemstrip Roche/Boehringer Mannheim 82044QW Beckman Coulter ICON Microalb Beckman Coulter 82044QW Diag. Chemicals ImmunoDip Urinary Albumin Test Diagnostic Chemicals 82044QW Diagnostic Chemicals Urinary Albumin Screen Urine Dipstick (microalbumin)

Diagnostic Chemicals Limited (USA) 82044QW

Page 38: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 38 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Genzyme Diagnostics OSOM ImmunoDip Urinary Albumin Test Genzyme Diagnostics 82044QW HemoCue Albumin 201 System (Albumin, Urinary) Hemocue AB 82043QW Siemens Clinitek 50 Chemistry Analyzer (see also under Urinalysis) Bayer 82044QW

Siemens Clinitek Status Urine Chemistry Analyzer Bayer HealthCare, LLC 82044QW Siemens Diag. MICROALBUSTIX Reagent Strips Bayer 82044QW

Mononucleosis Acceava Mono Cassette (WB) Biosite Inc 86308QW Acceava Mono II (whole blood) Biosite Inc 86308QW Acon Mono Rapid Test Strip/Device (whole blood) Acon Laboratories, Inc. 86308QW AimStep Mono (whole Blood) Princeton Biomedical Corp 86308QW Applied Biotech One Step+ Mono Test Applied Biotech, Inc 86308QW Applied Biotech SureStep Mono Test (whole blood) Applied Biotech, Inc 86308QW Applied Biotech Truview Mono Test Applied Biotech, Inc 86308QW Beckman Coulter Icon Mono Test (whole blood) Beckman Coulter, Inc 86308QW BioStar Acceava Mono Test (whole blood) BioStar, Inc. 86308QW BioStar Acceava Mono II (whole blood) Acon Laboratories, Inc. 86308QW Cardinal SP Brand Rapid Test Mono Applied Biotech, Inc. 86308QW Clarity MONO Mononucleosis Rapid Test (WB) Princeton Biomeditech Corp 86308QW Clearview Mono-Plus II Applied Biotech, Inc. 86308QW Clearview Mono Whole Blood Inverness Medical 86308QW Consult Diagnostics Mononucleosis Cassette (WB) Princeton BioMeditech Corp 86308QW DE Healthcare Products Truview Mono Test Applied Biotech, Inc. 86308QW Genzyme Contrast Mono (whole blood) Genzyme Diagnostics 86308QW Genzyme OSOM Mono Test Genzyme Diagnostics 86308QW Genzyme Rapid Mono (whole blood) Genzyme Diagnostics 86308QW Genzyme Sure-Vue Signature MONO Test (WB) Wyntek Diagnostics, Inc. 86308QW Henry Schein One Step+ Mono Test (whole blood) Applied Biotech, Inc. 86308QW Immuno Detector BioSign Mono WB Princeton Biomeditech Corp 86308QW Immuno Detector Mono WB Princeton Biomeditech Corp 86308QW Instant Technologies iScreen Mononucleosis Rapid Test Strip and Device Acon Laboratories, Inc 86308QW

Jant Accutest Infectious Mononucleosis (WB) Jant Pharmacal Corporation 86308QW Jant Accutest Value+ Mono Rapid Test (WB) Innovacon, Ind 86308QW Jant Pharmacal Corp, Accutest Rapid Mono Test (WB) Princeton Biomeditech Corp 86308QW LifeSign Status Mono Test (WB) LifeSign 86308QW LifeSign UniStep Mono Test (whole blood) LifeSign 86308QW Mckesson Consult Mononucleosis Test Cassette (WB) Princeton Biomeditech Corp 86308QW McKesson Medi-Lab Performance Infection Mononucleosis Test Applied Biotech, Inc. 86308QW Medi-Lab Performance Mononucleosis Test (WB) McKesson Medical/Surgical 86308QW Medline Mono Test Cassette (WB) Princeton BioMeditech Corp 86308QW Meridian ImmunCard STAT Mono (WB) Applied Biotech, Inc. 86308QW OneStep Pro+ Mono (WB) Princeton BioMeditech 86308QW PerMaxim RediScreen Mononucleosis (WB) Acon Laboratories, Inc. 86308QW Polymedco, Inc. Poly stat Mono for Infectious Mononucleosis [whole blood] Applied Biotech, Inc. 86308QW

Polymedco Polystat Mono(WB) Princeton BioMeditech Corp 86308QW Poly Stat Mono Test (WB) Innovacon 86308QW Princeton BioMeditech BioSign Mono WB Princeton BioMeditech 86308QW ProAdvantage by NDC Inf. Mono Test Device WB Biosite, Inc 86308QW Quidel CARDS O.S. Mono (for whole blood) Quidel 86308QW Quidel QuickVue+ Infectious Mononucleosis (WB) Quidel 86308QW

Page 39: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 39 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

RAC Medical Clarity MONO Rapid Test (WB) Acon Laboratories, Inc. 86308QW Rapid Response Mono Rapid Test Device (WB) Acon Laboratories, Inc. 86308QW Remel RIM A.R.C. Mono Test Applied Biotech, Inc. 86308QW Seradyn Color Q Mono Seradyn 86308QW Signify Mono Cassette (WB) Innovacon 86308QW Signify Mono Test Applied Biotech, Inc. 86308QW Signify Mono Whole Blood Inverness Medical 86308QW Stanbio Rely Mono Rapid Test (WB) Innovacon, Inc 86308QW Wampole Mono-Plus WB Wampole 86308QW Wyntek Diagnostics OSOM Mono test (WB) Wyntek Diagnostics 86308QW Wyntek Diagnostics Signify Mono Test (WB) Wyntek Diagnostics 86308QW

Nicotine (or its metabolites) CLIAwaived Instant Nicotine Detection Test Mossman Associates, Inc 80305QW DynaGen NicCheck 1 Test Strips DynaGen, Inc 80305QW Mossman Associates NicCheck I Test Strips Mossman Associates Inc 80305QW

Occult Blood

Fecal Occult Blood Various

82270 Immunoassay tests:82274QW G0328QW (screening series 1-3)

Fecal Occult Blood Immunochemical Tests Various 82274QW / G0328QW

Fecal Occult Blood Immunological Test (IFOBT) Various 82274QW / G0328QW

Aerscher Hemaprompt/FG (gastric occult blood) Aerscher Diagnostics 82271QW Alfa Scientific Designs Instant-View Fecal Occult Blood Self-Test (Cassette) Alfa Scientific Desgins, Inc Pending

Alfa Scientific Designs Fecal Occult Blood Self-Test Alfa Scientific Designs, Inc Pending Beckman Coulter Primary Care Diagnostics Gastroccult/Hemoccult Sensa Elite (gastric occult blood) Beckman Coulter, Inc. 82271QW

BTNX Inc. Rapid Response Fecal Occult Blood (FOB) Self Test Alfa Scientific Designs, Inc 82274QW/ G0328QW

Compliance Gold Fecal Occult Blood Test - ER Immunostics, INC. 82274QW / G0328QW

Eiken Chemical Co., LTD OC-Light S FIT (1) Eiken Chemial Co. LTD Pending Germaine Laboratories AimStep Immunological Fecal Occult Blood Test (iFOBT) New Bay Bioresearch Co Old 82274QW /

G0328QW

Hema Screen Specific iFOBT Immunostics, INC. 82274QW / G0328QW

Immunostics, Inc hema screen ER Immunostics, Inc 82274QW / G0328QW

Know Fecal Occult Blood (FOB) Self Test Alfa Scientific Designs, Inc 82274QW / G0328QW

Medline iFOB TEST Princeton BioMeditech Corporation

82274QW G0328QW

Rapid Response Fecal Occult Blood (FOB) Self Test Alfa Scientific Designs, Inc 82274QW / G0328QW

Page 40: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 40 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Rapid ResponseI FIT-Fecal Immunochemical Test Orient Gene Biotech 82274QW/ G0328QW

Sekisui Daignostics, LLC OSOM iFOB Test Princeton Biomeditech Corporation

82274QW/ G0328QW

Siemens Hematest Reagent Tablets Siemens Healthcare Diagnostics Pending

SmithKline Gastroccult SmithKline 82271QW

Tanner Scientific iFOB One Step Rapid Test Zhejiang Orient Gene Biotech Co., Lts Pending

Osmolarity TearLab Corp TearLab Osmolarity System (tears) TearLab Corporation 83861QW

Osteoporosis

Ostex International Osteomark NTX Point-of-care prescription home use (collagen type I crosslink, N-Telopeptides (NTX) Ostex International, Inc. 82523QW

Ovulation Tests Visual color comparison tests for human LH Various 84830 BTNX Inc Rapid Response LH Ovulation Test Ind Diagnostic Inc Pending Luna Fertility Indicator (saliva) Luna Pending O2 Unlimited Donna Ovulation Tester (saliva) O2 Unlimited 87210QW Stesans Maybe?Mom Mini Ovulation Microscope (saliva) Maybe? M.O.M., Inc. 87210QW TCI Ovulation Tester (saliva) TCI New York 87210QW

PH All qualitative color comparison pH testing body fluids (other than blood) Various 83986QW

Common Sense Ltd Fem-V Test Kit (vag pH) Common Sense, Ltd 83986QW Common Sense Ltd VA-SENSE Kit (vag pH) Common Sense, Ltd 83986QW Common Sense Ltd Norma-Sense Vag Discharge pH Common Sense, Ltd 83986QW Common Sense Ltd VI-SENSE Acidity (vag pH) Common Sense, Ltd 83986QW Common Sense Ltd VS-SENSE Test (vag pH) Common Sense, Ltd 83986QW Dale Med Prod. RightLevel pH (gastric pH) EZ-NG LLC 83986QW Dale Med Prod. RightSpot pH (gastric pH) EZ-NG LLC 83986QW Duramed Pharmaceuticals AmniScreen Home Detection Liner Kit Common Sense, Ltd 83986QW Femtek Phem-Alert (vaginal pH) Femtek, LLC 83986QW Lil’ Drug Store Products Vagi-Screen Vaginal Health Test (vaginal pH) Lil’ Drug Store Products Inc 83986QW

Litmus Concepts FemExam Test Card (vaginal pH and amines) Litmus Concepts, Inc. 82120QW amines

Quidel QuickVue Advance pH and Amines Test Quidel Corporation 82120QW amines

RightBio Metrics, RightSpot Infant pH Indicator Right Bio Metrics 83986QW Phosphorus

Abaxis Piccolo Blood Chem Analyzer WB (Renal Panel) Abaxis, Inc 84132QW Piccolo xpress Chem Analyzer WB (Renal Panel) Abaxis, Inc 84132QW

Platelet Aggregation Accumetrics Verify Now Aspirin Assay Accumetrics, Inc 85576QW

Potassium Abaxis Piccolo Blood Chem Analyzer WB (CMP, BMP, Electrolyte, Metlyte 8, Renal) Abaxis, Inc 84132QW

Page 41: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 41 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Abaxis Piccolo xpress Chem Analyzer WB(CMP, BMP, Electrolyte, Metlyte 8, Renal) Abaxis, Inc 84132QW

Abbott i-STAT 3+ Cartridge (WB) i-STAT Corporation 84132QW Abbott i-STAT 4+ Cartridge (WB) i-STAT Corporation 84132QW Abbott i-STAT 6+ Cartridge (WB) i-STAT Corporation 84132QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 84132QW

Pregnancy Test (URINE) Visual Color Comparison tests Various 81025 Siemens Clinitek 50 Chemistry Analyzer (see also under Urinalysis) Siemens 84703QW

Siemens Clinitek Status Urine Chemistry Analyzer Siemens 84703QW Protime (Prothrombin Time)

Alere INRatio2 PT/INR (professional/home use) Alere, Inc 85610QW AvoSure PT System (prescription home use) Avocet Medical, Inc. 85610QW AvoSure PRO (Professional Use) Avocet Medical, Inc. 85610QW CoaguSense Prothrombin Time (PT/INR) Coagusense, Ind 85610QW CoaguSense Self-Test Protime/INR (Prescription Home Use) Coagusense, Inc. 85610QW Hemosense INRATIO System Hemosense, Inc. 85610QW International Technidyne Protime Microcoagulation System International Technidyne Corp 85610QW International Technidyne Protime Microcoagulation System ProTime 3 Cuvette International Technidyne Corp 85610QW

Lifescan Harmony INR Monitoring System (Prescription Home Use and Professional Use) (reports INR only) Lifescan 85610QW

Lifescan Rubicom Prothrombin Time Monitoring System Lifescan, Inc. 85610QW Roche Diagnostics CoaguChek-PST for prothrombin time Roche Diagnostics 85610QW Roche Diagnostics CoaguChek and CoaguChek S System, PT-S Test Strips (prothrombin time) Roche Diagnostics 85610QW

Roche Diagnostics CoaguChek XS (prothrombin time) Roche Diagnostics 85610QW Roche Diagnostics CoaguChek XS Plus (prothrombin time) Roche Diagnostics 85610QW

Protein, Total Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP) Abaxis, Inc 84155QW Abaxis Piccolo xpress Chemistry Analyzer WB (Liver Panel Plus) Abaxis, Inc 84155QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc)(WB) Abaxis, Inc. 84155QW

Abaxis Piccolo xpress Chem Analyzer WB (Chem 13, CMP) Abaxis, Inc 84155QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 84155QW

Renal Function Panel Abaxis Piccolo Blood Chem Analyzer WB (Renal Function Panel) Abaxis, Inc 80069QW Abaxis Piccolo express Chem Analyzer WB (Renal Function Panel) Abaxis, Inc 80069QW

RSV (Respiratory Syncytial Virus) Alere BixaxNOW RSV Card Alere Scarborough, Inc 87807QW Cepheid Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) Cepheid 87807QW

Cobas RSV Nucleic Acid Test for Use on the cobas Liat System IQUUM, INC 87807QW BD Veritor System for Rapid Detection of RSV Becton Dickinson & Co 87807QW Binax NOW RSV Test (RSV antigen, qual) Binax, Inc. 87807QW Fisher Scientific Sure-Vue RSV Test SA Scientific, Inc. 87807QW Integrated Biotechnology Quick Lab RSV Test (direct antigen, qualitative) Integrated Biotechnology, Corp 87807QW

Meridian Biosci. Immunocard Stat! RSV Plus Meridian Bioscience, Inc. 87807QW

Page 42: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 42 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Quidel Quick Vue RSV Test Quidel Corp 87807QW Rapid Response RSV Test Sa Scientific Inc 87807QW Remel Xpect RSV SA Scientific, Inc. 87807QW SA Scientific SAS RSV Alert SA Scientific, Inc. 87807QW SA Scientific SAS RSV Test SA Scientific, Inc. 87807QW Sofia RSV Quidel Corporation 87807QW Wampole Laboratories Clearview Integrated Biotechnology Corp 87807QW

Semen Embryotech Laboratories FertiMARQ Home Diagnostic Screening Test for Male Infertility Embryotech Laboratories, Inc. 89300QW

Fertell Male Fertility Test Genosis, LTD 89321QW Fertility Solutions Semen Analysis Qualitative Fertility Solutions 89300QW SpermCheck Fertility Princeton Biomeditech Corp Pending SpermCheck Vasectomy Princeton Biomeditech Corp 83900QW Trak Male Fertility Testing System Sandstone Diagnostics, Inc Pending

YO Home Sperm Test Medical Electronic Systems, LTD Pending

Sodium Abaxis Piccolo Blood Chem Analyzer WB (CMP, BMP, Electrolyte, Metlyte 8, Renal) Abaxis, Inc 84295QW

Abaxis Piccolo xpress Chem Analyzer WB(CMP, BMP, Electrolyte, Metlyte 8, Renal) Abaxis, Inc 84295QW

Abbott i-STAT 3+ Cartridge (WB) i-STAT Corporation 84295QW Abbott i-STAT 4+ Cartridge (WB) i-STAT Corporation 84295QW Abbott i-STAT 6+ Cartridge (WB) i-STAT Corporation 84295QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 84295QW

Strep Antigen Test Abbott Signify Strep A Dipstick Innovacon 87880QW Abbott Signify Strep A Test Wyntek 87880QW Acceava Strep A Twist Rapid Test Innovacon 87880QW Acceava Strep A Test Innovacon 87880QW Accustrip Strep A Princeton Biomeditech Corp 87880QW Acon Strep A Rapid Strip Test Acon 87880QW Acon Strep A Twist Rapid Test Acon 87880QW Alere, Strep A, Alere I Instrument Alere Scarborough, Inc 87880QW Applied Biotech SureStep Strep A (II) Applied Biotech, Inc 87880QW Applied Biotech SureStep Strep A Exact Applied Biotech, Inc 87880QW BD Veritor System for Rapid Detection of Group A Strep Becton Dickinson & Co. 87880QW Beckman Coulter ICON DS Strep A Test Princeton BioMeditech 87880QW Beckman Coulter ICON FX Strep A Test (formerly SmithKline) Binax 87880QW Beckman Coulter Primary Care Diagnostics ICON DS Strep A Test Acon Laboratories 87880QW Beckman Coulter Primary Care Diagnostics ICON SC Strep A Test Acon Laboratories 87880QW Beckman Coulter Primary Care Diagnostics ICON FX Strep A Immunochemical Strep A Antigen Test Beckman Coulter, Inc. 87880QW

Becton Dickinson Chek Group A Strep Test Innovacon, Ind 87880QW Becton Dickinson LINK 2 Strep A Rapid Test Becton Dickinson 87880QW Binax Clearview Advanced Strep A Binax, Inc 87880QW Binax NOW Strep A Test Binax, Inc 87880QW BioStar Acceava Strep A Test BioStar 87880QW Biotechnostix Rapid Response Strep A Rapid Test Devise/Strip Acon Laboratories 87880QW BTNX Rapid Response Strep A Rapid Test Strips Sa Scientific, Inc 87880QW

Page 43: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 43 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Cardinal Health SP Brand Rapid Test Strep A Dipstick / Rapid Test Strep A Cassette Applied Biotech, Inc. 87880QW

Cardinal Health Strep A Cassette and Dipstick-Rapid Test Alere Sd 87880QW Clearview Strep A Exact Dipstick Applied Biotech, Inc. 87880QW CLIA Waived Inc Rapid STREP A Test Sa Scientific Inc 87880QW Consult Diagnostics STREP A Rapid Dipstick Innovacon, Inc 87880QW CTMI Strep A Rapid Test Strip Innovacon, Ind 87880QW DE Healthcare Products, TruView Strep A Test / Strep A Cassette DE Healthcare Products 87880QW Diagnostic Test Group Clarity Strep A Rapid Test Strips Princeton BioMeditech Corp 87880QW Fisher HealthCare Sure-Vue Strep A (direct from throat) Applied Biotech, Inc. 87880QW Genzyme Contrast Strep A Genzyme Diagnostics 87880QW Genzyme OSOM Ultra Strep A Test (25 test kit) Genzyme Diagnostics 87880QW Germaine Laboratories StrepAim Rapid Dipstick Test (Strep Group A) Acon Laboratories, Inc. 87880QW

Germaine Laboratories Strep AIM Tower Acon Laboratories, Inc. 87880QW Henry Schein Inc, OneStep+ Strep A Test / OneStep+ Strep A Dipstick Test / OneStep+ Strep A Cassette Test / OneStep Pro+ Henry Schein, Inc 87880QW

ICON DS Strep A Test ACON Laboratories, Inc. 87880QW IMI Signify Strep A Dipstick Innovacon Inc 87880QW Immunostics Detector Strep A Direct ACON Laboratories, Inc. 87880QW Immunostics Immuno/StrepA Detector ACON Laboratories, Inc. 87880QW Instant Tech iStrep One Step Strep A Test ACON Laboratories, Inc. 87880QW Inverness Med BioStar Acceava Strep A Test ACON Laboratories, Inc. 87880QW Inverness Med BioStar Acceava Strep A Twist Innovacon, Inc 87880QW Inverness Medical Clearview Strep A Exact II Dipstick Innovacon, Inc. 87880QW Inverness Medical Signify Strep A Cassette Innovacon, Inc 87880QW Jant Pharmacal AccuStrip Strep A (II) Jant Pharmacal 87880QW Jant Pharmacal AccuStrip Strep A Value+ Test Strip Innovacon 87880QW Jant Pharmacal Accutest Integrated Strep A Rapid Test Device Jant Pharmacal 87880QW Jant Pharmacal Clinipak Strep A Rapid Test Strip Jant Pharmacal 87880QW Laboratory Supply Company (LSC) PEP Strep A Cassette / PEP Strep A Dipstick Test Acon Laboratories Co 87880QW

LABSCO Advantage Strep A Princeton BioMediTech Corp 87880QW Roche Molecular, cobas Liat System IQuum, Inc. 87880QW LifeSign LLC Status Strep A Princeton BioMediTech Corp 87880QW Mainline Confirms Strep A Dots Test Mainline Technology, Inc 87880QW McKesson Consult Diagnostics Strep A Test Dipstick Alere 87880QW McKesson Medi-Lab Performance Strep A Test Dipstick/Cassette Applied Biotech, Inc. 87880QW McKesson Medi-Lab Strep A Test Dipstick Innovacon, Inc. 87880QW McKesson Medi-Lab Strep A Test – Twist Innovacon, Inc. 87880QW McKesson Strep A Test Dipstick/Cassette Applied Biotech, Inc. 87880QW Medline Strep A Test Strips {Throat Swabs} Alere, INC. 87880QW MediLab Performance Strep A Twist Rapid Test MediLab 87880QW Meridian Diag. ImmunoCard STAT Strep A Meridian Diagnostics 87880QW Moore Medical The Supply Experts Strep A Test – Cassette Innovacon, Inc 87880QW Moore Medical The Supply Experts Strep A Rapid Test – Dipstick Innovacon 87880QW Mooremedical Strep A Rapid Test – Dipstick Alere San Diego Inc 87880QW PEP Performance Enhanced Products Strep A Cassette Test / Strep A Dipstick Acon Laboratories 87880QW

PerMaxin Rediscreen Strep A Rapid Test Acon Laboratories 87880QW PerMaxin Rediscreen Strep A Twist Cassette Innovacon 87880QW

Page 44: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 44 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Polymedco, Inc. Poly Stat A (II) for Group A Strep [direct from throat swab] Applied Biotech, Inc. 87880QW

Poly stat Strep A Flip Test Princeton BioMediTech Corp 87880QW Poly stat Strep A Strip Test Princeton Biomeditech Corp 87880QW Polymedco Poly Stat Strep A Dipstick Innovacon 87880QW Polymedco Poly Stat Strep A Liquid Test Polymedco 87880QW Princeton BioMediTech BioStrep A Test Princeton BioMediTech Corp 87880QW Princeton Biomeditech Status First Strep A Princeton BioMediTech Corp 87880QW ProAdvantage by NDC Strep A Test Innovacon 87880QW PSS Consult Diagnostics Strep A Dipstick Innovacon 87880QW PSS World Medical Select Diagnostics Strep A Dipstick Innovacon 87780QW PSS World Medical Select Diagnostics Strep A Twist Innovacon 87780QW Quidel QuickVue Dipstick Strep A Quidel 87880QW Quidel QuickVue In-Line Strep A Quidel 87880QW Quidel QuickVue In-Line One-Step Strep A Quidel 87880QW Quidel Sofia Strep A+ FIA (from throat swab only) Quidel Corp 87880QW RAC Medical Clarity Strep A Twist Rapid Strep Test Device/Strip Acon laboratories, Co 87880QW SMC Direct, LLC, RefuAH Strep A Rapid Wondfo Biotech Co., LTD. 87880QW Remel RIM A.R.C. Strep A Test (direct from throat swab) Applied Biotech, Inc. 87880QW SA Scientific SAS Strep A (direct from throat swab) SA Scientific, Inc. 87880QW Sacks Medical Refuah Strep A Rapid Test Acon Laboratories 87880QW StatusFirst Strep A Princeton BioMeditech Corp 87880QW Select Medical Products Brand Rapid Test Strep A Dipstick Innovacon, Inc 87880QW Sekisui Diag OSOM Strep A Test (direct throat swab) Sekisui Diagnostics 87880QW Sekisui Diag OSOM Ultra Strep A Test Sekisui Diagnostics 87880QW Select Medical Products Brand Rapid Test Strep A Twist Innovacon, Inc 87880QW Signify Strep A Dipstick Applied Biotech, Inc. 87880QW SmithKline ICON Fx Strep A Test (from throat swab only) Binax 87880QW Stanbio Laboratory E-Z Well Strep A Rapid Device Test Acon Laboratories Co 87880QW Stanbio Qustick Strep A Acon Laboratories Co 87880QW StrepAim Princeton Biomeditech Corp 87880QW

Wondofo One Step Strep A Swab Test Guangzhou Wondfo Biotech Co., LTD. 87880QW

Wyntek Diagnostics OSOM Strep A Test Wyntek Diagnostics, Co 87880QW Wyntek Diagnostics OSOM Ultra Strep A Test Wyntek Diagnostics, Co 87880QW

Syphilis Diagnostics Direct LLC Syphilis Health Check (Fingerstick WB Only) Diagnostics Direct LLC 86780QW

Trichomonas Genzyme Osom Trichomonas Rapid Test Genzyme Corp 87808QW Sekisui Diag OSOM Trichomonas Rapid Test Genzyme Corp 87808QW

Triglycerides Abaxis Piccolo xpress Chemistry Analyzer {capillary-finger stick} (Triglyceride) Abaxis, Inc. 84478QW

Abaxis Piccolo express Chemistry Analyzer WB (Lipid Panel/Lipid Panel Plus) Abaxis, Inc 84478QW

Abaxis Piccolo POC/xpress Chemistry Analyzer WB (Lipid Panel/Lipid Panel Plus) Abaxis, Inc 84478QW

Alere Cholestech LDX (triglyceride)(WB) Alere, Inc 84478QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 84478QW Cholestech LDX (Must have software version 1.40 or above) Cholestech 84478QW

Page 45: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 45 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Infopia USA LipidPro Infopia Co Ltd 84478QW Infopia USA LipidPro Professional Lipid Profile and Glucose Measuring System Infopia Co Ltd 82465QW

Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System Infopia Co, Ltd 84478QW

Polymer Technology Systems, Inc, BioScanner, Bioscanner Plus, Bioscanner 2000

Polymer Technology Systems, Inc. 84478QW

Polymer Technology Systems Cardiochek Plus, Cardiochek Home Use and Cardiochek PA Analyzer test strips

-PTS panels Lipid Panel test strips -CardioChek Home Lipid Panel test strips

Polymer Technology Systems, Inc. 84478QW

Wako APOLOWAKO Analyzer Wako Chemicals USA 84478QW TSH

Aventir Biotech LLC FORSURE TSH (WB) Screening Devices Canada Inc 84443QW BTNX Inc Rapid Response TSH (WB) Screening Devices Canada Inc 84443QW CLIA waived Inc Thyroid Test Rapid TSH Cassette (WB) Screening Devices Canada Inc 84443QW

Germaine Laboratories, Inc AimStep Thyroid Screen (WB) Screening Devicdes Canada, Inc 84443QW

Little Nell Labs ThyroChek TSH (WB) Little Nell Labs, Inc. 84443QW Jant Pharmacal Corp Accutest TSH (WB) Screening Devices Canada 84443QW Pharmaceutical Marketing Thyrotest TSH (WB) Screening Devices Canada 84443QW Qualigen Inc FastCheck TSH (WB) Screening Devices Canada 84443QW ThyroTest Whole Blood TSH Test (WB) ThyroTec, Inc. 84443QW

Uric Acid Abaxis Piccolo Blood Chemistry Analyzer (Chem 13 Panel) (WB) Abaxis, Inc. 84550QW Abaxis Piccolo xpress Chemistry Analyzer (Chem 13 Panel) (WB) Abaxis, Inc. 84550QW

Urinalysis Dipstick or tablet reagent urinalysis {nonautomated} (bilirubin---ketone---protein---urobilinogen---blood--- leukocytes--pH--ascorbic acid--- glucose--- nitrite---sp gr)

Various 81002

Acon Laboratories Insight U120 Urine Analyzer (bilirubin---ketone--- protein--- urobilinogen---blood--- leukocytes--- pH---glucose--- nitrite--- sp gr)

Acon Laboratories, Inc 81003QW

Acon Laboratories Mission UTI Urinary Tract Infection Test Strips (leukocyte esterase, nitrite) Acon Laboratories, Inc Pending

Acon Mission U120 Urine Analyzer (bilirubin---ketone--- protein---urobilinogen--- blood--- leukocytes---pH---glucose--- nitrite---sp gr) Acon Laboratories, Inc 81003QW

Acon Mission Foresight U120 Urine Analyzer Acon Laboratories, Inc 81003QW Biosys Laboratories Optima Urine Analyzer (bilirubin--- ketone--- protein--- urobilinogen--- blood--- leukocytes---pH--- glucose--- nitrite---sp gr)

Biosys Laboratories 81003QW

Biosys Laboratories Optima II Urine Analyzer (bilirubin---ketone--- protein--- urobilinogen--- blood---leukocytes--- pH--- glucose---nitrite---sp gr)

Biosys Laboratories 81003QW

BTNX Rapid Response U120 Urine Analyzer (bilirubin---keton--- protein---urobilinogen--- blood--- leukocyte---pH---glucose---nitrite---sp gr)

Acon Laboratories 81003QW

Chemstrip Mini UA (bilirubin---ketone---protein---urobilinogen---blood--- leukocyte---pH---glucose---nitrite---sp gr) Roche/Boehringer Mannheim 81003QW

Clarity Diagnostics LLC, Clarify U122 Urine Analyzer (bilirubin---ketone---protein---urobilinogen---blood--- leukocytes---pH---glucose---nitrite---sp gr)

ACON Laboratories, INC 81003QW

Page 46: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 46 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Cole-Taylor Marketing Inc CTI-120 Urine Strip Analyzer (bilirubin--- ketone---protein---urobilinogen---blood--- leukocytes---pH---glucose---nitrite---sp gr)

Acon Laboratories Inc 81003QW

Consult diagnostics Urine Analyzer (bilirubin--- ketone---protein--- urobilinogen---blood--- leukocyte---pH---glucose---nitrite---sp gr) Yd Diagnostics 81003QW

Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer (bilirubin---ketone--- protein---urobilinogen---blood--- leukocytes--- pH---glucose--- nitrite---sp gr)

Acon Laboratories, Inc 81003QW

Express Diagnostics International, Incorporated UTI Test Strips(leukocyte esterase, nitrite) Teco Diagnostics 81003QW

Express Diagnostics International, Incorporated Urine Reagent Strips 10 for Urinalysis (bilirubin---ketone--- protein---urobilinogen---blood---leukocytes---pH---glucose--- nitrite---sp gr)

Teco Diagnostics 81003QW

Germaine Laboratories AimStrip Urine Analyzer (bilirubin---ketone--- protein--- urobilinogen--- blood--- leukocytes--- pH---glucose---nitrite---sp gr)

Acon Laboratories, Inc 81003QW

Germaine Laboratories, Inc. AimStrip Urine Analyzer 2 System (AimStrip Urine reagent Strips and Fisherbrand Urine Reagent Strips) (urobilinogen, glucose, leukocytes, ascorbic acid, ketone, blood, specific gravity, nitrite, protein, bilirubin, pH)

AimStrip Urine Analyzer 2 81003QW

Henry Schein OneStepPlus Urine Analyzer (bilirubin--- ketone--- protein---urobilinogen---blood--- leukocytes--- pH---glucose--- nitrite---sp gr---ascorbic acid)

Macheerey-Nagel GmbH & Co 81003QW

Henry Schein Urispec Plus Urine Analyzer (bilirubin---ketone---protein---urobilinogen---blood--- leukocytes---pH---glucose---nitrite--- sp gr)

Macheerey-Nagel GmbH & Co 81003QW

Hypoguard Diascreen 50 Urine Chemistry Analyzer (bilirubin---ketone---protein---urobilinogen---blood--- leukocytes---pH---glucose---nitrite---sp gr)

Hypoguard 81003QW

Immunostics Inc Detector Uristrip+ Analyzer (bilirubin---ketone---protein---urobilinogen---blood---leukocytes--- pH---glucose--- nitrite--- sp gr)

Acon Laboratories 81003QW

Jant Pharmacal Corporation Accustrip URS Reader (bilirubin---ketone---protein---urobilinogen---blood--- leukocytes---pH---glucose---nitrite---sp gr)

Macherey-Nagel GmbH & Co 81003QW

McKesson 120 Urine Analyzer (bilirubin---ketone---protein---urobilinogen---blood--- leukocytes---pH---ascorbic acid---glucose---nitrite ---sp gr)

Acon Laboratories 81003QW

Mckesson Consult 120 Urine Analyzer (ascorbic acid, bilirubin, blood, glucose, ketone, leukocytes, Ph, protein, nitrite, specific gravity, urobilinogen)

Teco Diagnostics 81003QW

Mediwatch urine watch Urine Analyzer (bilirubin--- ketone--- protein ---urobilinogen---blood--- leukocytes---pH---glucose---nitrite---sp gr) Acon Laboratories, Inc 81003QW

Medline 120 Urine Analyzer (bilirubin---ketone---protein---urobilinogen---blood---leukocytes---pH---glucose---nitrite---sp gr) Acon Laboratories, Inc 81003QW

Moore Medical Urine Analyzer U120 (ascorbic acid---bilirubin---ketone---protein---urobilinogen---blood--- leukocytes---pH---glucose---nitrite---sp gr)

Acon Laboratories, Ind 81003QW

NDC Inc Pro Advantage by NDC Urine Analyzer (bilirubin---ketone---protein---urobilinogen---blood--- leukocytes---pH---glucose---nitrite---sp gr)

Acon Laboratories, Inc 81003QW

Page 47: CLIA Waived Tests and CPT Codes

DOH 681-018 April 2017 Page 47 of 47

Test Name/Specific Test System Manufacturer Approved

CPT Code(s)

Physician Sales Service PSS Select Urine Analyzer (bilirubin---ketone---protein---urobilinogen ---blood---leukocytes---pH---glucose---nitrite---sp gr)

Physician Sales and Services, Inc 81003QW

RefuAH U120 Urine Analyzer (bilirubin---ketone---protein---urobilinogen---blood---leukocytes--- pH--- glucose ---nitrite---sp gr) Acon Laboratories, Inc 81003QW

Roche Diagnostics Urisys 1100 Urine Analyzer (bilirubin--- ketone--- protein---urobilinogen---blood--- leukocytes ---pH---glucose ---nitrite ---sp gr)

Roche Diagnostics Corp 81003QW

Roche Diagnostics Chemstrip 101 Urine Analyzer- (bilirubin---ketone---protein---urobilinogen ---blood--- leukocytes---pH---glucose---nitrite---sp gr)

Roche/Boehringer Mannheim 81003QW

Siemens Clinitek 50 Urine Chemistry Analyzer (bilirubin---ketone--- protein---urobilinogen---blood--- leukocytes---pH---HCG---glucose---nitrite ---sp gr---creatinine microalbumin)

Siemens 81003QW

Siemens Clinitek Status Urine Chemistry Analyzer (bilirubin---ketone---protein---urobilinogen---blood--- leukocytes---pH---glucose---nitrite---sp gr---creatinine---microalbumin)

Siemens 81003QW

Siemens Clinitek Status+ Analyzer (bilirubin---ketone---protein---HCG---blood ---leukocytes---pH-glucose---nitrite---sp gr---creatinine---microalbumin)

Siemens 81003QW

Siemens Clinitek Status Connect System (bilirubin---ketone---protein---HCG---blood---leukocytes---pH---glucose---nitrite---sp gr---creatinine---microalbumin)

Siemens 81003QW

Stanbio Uri-Trak 120 Urine Analyzer bilirubin--- ketone---protein---glucose---blood---leukocytes---pH---urobilinogen---nitrite---sp gr) Acon Laboratories, Inc 81003QW

ThermoBiostar PocketChem UA (bilirubin---ketone---protein---urobilinogen---blood---leukocytes---pH---glucose---nitrite---sp gr) Arkray 81003QW