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Simplifying your quality controls Thermo Scientific MAS Quality Control Products LabLink xL Quality Assurance Program North America Catalog

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Page 1: Thermo Scientific MAS Quality Control Products LabLink xL ......Lipoprotein A (Lp(a))* Prealbumin ... CA 125 CA 15-3 CA 19-9 Carcinoembryonic Antigen (CEA) Gastrin Prostatic Acid Phosphatase

Simplifying your quality controls Thermo Scientific MAS Quality Control ProductsLabLink xL Quality Assurance ProgramNorth America Catalog

Page 2: Thermo Scientific MAS Quality Control Products LabLink xL ......Lipoprotein A (Lp(a))* Prealbumin ... CA 125 CA 15-3 CA 19-9 Carcinoembryonic Antigen (CEA) Gastrin Prostatic Acid Phosphatase

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Discover #MASproductivity

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Thermo Scientific MAS Controls

Omni Consolidated Controls 4-7

Serum Chemistries 8-9

Urine Chemistries 10-11

Immunoassay 12-13

Cardiac & Diabetes 14

Immunology & Protein 15

Toxicology 16

Dimension Vista Controls 17-19

Thermo Scientific MAS Programs

LabLink xL Quality Assurance Software 20-23

Value Assignment Program 24

Thermo Scientific MAS Control ReferencesAnalytes 26-30

Instruments 31-34

General Ordering Information

To Place An Order 35

Technical Service & Support 35

Contents

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Thermo Scientific MASOmni Consolidated Controls

Part Number Level Bottles & Size Storage & Stability Matrix

OCR-101 1

6 x 5 mL Assayed

36 month shelf life @ -25 to -15 ºC

from date of manufacture30 days open vial @ 2 to 8 ºC

(Bilirubin is 15 days open vial @ 2 to 8 ºC)

Human SerumOCR-202 2

OCR-303 3

Omni•COREThermo Scientific™ MAS™ Omni•CORE™ Controls consolidate general chemistry and serum protein QC processing into a single product, offering three distinct levels.

Analytes

General ChemistryAlbuminAlkaline Phosphatase (ALT/GPT)Alanine Aminotransferase (ALT)AmylaseAmylase (Pancreatic)*Aspartate Aminotransferase (AST/GOT)Bile Acids*Bilirubin, ConjugatedBilirubin, Direct (DBIL)Bilirubin, NeonatalBilirubin, Total (TBIL)Bilirubin, UnconjugatedBlood Urea Nitrogen (BUN)CalciumCarbon Dioxide (CO2)ChlorideCholesterolCholesterol, HDLCholesterol, LDLCopper*Creatine Kinase (CK)CreatinineGamma-Glutamyl Transferase (GGT)Glucose Lactate Dehydrogenase (LDH)

Lactic AcidLipaseMagnesiumOsmolalityPhosphorusPotassiumPseudocholinesterase (PCHE)SodiumTotal ProteinTriglyceridesUric AcidZinc

TDM/Toxicology TestsAcetaminophenAmikacinCaffeineCarbamazepineDigoxinDisopyramideEthanolEthosuximideGentamicinLidocaineLithium Methotrexate

N-acetylprocainamide (NAPA)PhenobarbitalPhenytoinPrimidoneProcainamideQuinidineSalicylateTheophyllineTobramycinTricyclic Antidepressants (TCA)Valproic AcidVancomycin

Anemia/Iron Deficiency TestsFerritinIronIron Binding Capacity (IBC)Iron Binding Capacity, Total (TIBC)Iron Binding Capacity, Unsaturated (UIBC)Transferrin*

Thyroid Function TestsThyroxine, Total (TT4)Thyroid-Stimulating Hormone (TSH)Thyroid Uptake (T-Uptake)

Endocrine/Hormone TestsCortisol

Allergy TestsImmunoglobulin E (IgE)

Serum Proteins/Serology TestsAlpha-1-Acid Glycoprotein (AAG)*Alpha-1-Antitrypsin (AAT)*Alpha-2-Macroglobulin (AMG)*Antistreptolysin O (ASO)Apolipoprotein A1 (APO A)*Apolipoprotein B (APO B)*Beta-2-MicroglobulinC3 Complement*C4 Complement*Ceruloplasmin (CER)*C-Reactive Protein (CRP)Haptoglobin*Immunoglobulin A (IgA)*Immunoglobulin G (IgG)*Immunoglobulin M (IgM)Lipoprotein A (Lp(a))*PrealbuminRheumatoid Factor (RF)

* These constituent levels have not been adjusted but are at levels found in the source material used in preparation of the controls. No claim is made for expected values of these constituents.

Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

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Omni•CARDIO Thermo Scientific™ MAS™ Omni•CARDIO™ Controls consolidate a comprehensive cardiac marker panel with the new generation of STAT analytes including D-Dimer, hCG, Myeloperoxidase and Procalcitonin.

Part Number Level Bottles & Size Storage & Stability MatrixOCRD-UL Ultra Low

6 x 3 mL Assayed

36 months @ -25 to -15 ºC

from date of manufacture15 days @ 2-8 ºC (for BNP-32, CK-MB, D-Dimer, Digitoxin,

hCG, hsCRP, Myeloperoxidase, Procalcitonin, Total CK, Troponin-I and Troponin-T)

10 days @ 2-8 ºC (for Myoglobin and NT-proBNP)

Human Serum

OCRD-L Low

OCRD-101 1

OCRD-202 2

OCRD-303 3

OCRD-MPTri-Level Multi-Pack

(2 vials each level 1/2/3)

Analytes

Brain Natriuretic Peptide-32 (BNP-32)Creatine Kinase MB (CK-MB)D-DimerDigitoxinHuman Chorionic Gonadotropin (hCG)

Beta Human Chorionic Gonadotropin (Beta-HCG)High Sensitivity C-Reactive Protein (hsCRP)Myeloperoxidase (MPO)MyoglobinN-Terminal Brain Natriuretic Peptide (NT-proBNP)

Procalcitonin (PCT)Total Creatinine Kinase (Total CK)Troponin ITroponin T

Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

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Omni•IMMUNEThermo Scientific MAS Omni•IMMUNE™ & Omni•IMMUNE PRO™ Controls provide consolidation for routine immunoassay, tumor marker and specialty immunoassay QC processing into a single product, offering three distinct levels.

Part Number Level Bottles & Size Storage & Stability Matrix

OPRO-101 1

6 x 5 mL Assayed36 month shelf life @ -25 to -15 ºC

from date of manufacture30 days open vial @ 2 to 8 ºC

Human SerumOPRO-202 2

OPRO-303 3

Part Number Level Bottles & Size Storage & Stability Matrix

OIM-101 1

6 x 5 mL Assayed36 month shelf life @ -25 to -15 ºC

from date of manufacture30 days open vial @ 2 to 8 ºC

Human SerumOIM-202 2

OIM-303 3

Omni•IMMUNE PROThermo Scientific MAS Omni•IMMUNE PRO™ Controls provide Anti-Thyroglobulin (Anti-Tg), Anti-Thyroid Peroxidase (Anti-TPO) and Sex Hormone Binding Globulin (SHBG), in addition to the same analyte panel provided in the MAS Omni•IMMUNE product.

* These constituent levels have not been adjusted but are at levels found in the source material used in preparation of the controls. No claim is made for expected values of these constituents.

Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

Dropper Tips - Pkg 100 - MAS P/N 286-606

New Specialty Tests25-Hydroxy Vitamin DAnti-Thyroglobulin (Anti-Tg) (PRO)Anti-Thyroid Peroxidase (Anti-TPO) (PRO)C-PeptideEstriol, FreeFructosamine*IGF-1 (insulin-like growth factor 1)Phenytoin, FreePregnancy Associated Plasma Protein A (PAPP-A)*Procalcitonin (PCT)Parathyroid Hormone (PTH)Sex Hormone-Binding Globulin (SHBG) (PRO)Thyroxine-Binding Globulin (TBG)Valproic Acid, Free

TDM/Toxicology TestsAcetaminophenAmikacinBenzodiazepine (Nordiazepam)CarbamazepineDigoxinDisopyramideEthosuximide

GentamicinLidocaineLithiumN-acetylprocainamide (NAPA)PhenobarbitalPhenytoinPrimidoneProcainamideQuinidineSalicylateTheophyllineTobramycinTricyclic Antidepressants (TCA)Valproic AcidVancomycin

Thyroid Function TestsTriiodothyronine, Free (FT3)Triiodothyronine, Total (TT3)Thyroxine, Free (FT4)Thyroxine, Total (TT4)ThyroglobulinThyroid-Stimulating Hormone (TSH)Thyroid Uptake (T-Uptake)

Tumor Marker TestsAdrenocorticotropic Hormone (ACTH)Beta-2-microglobulinCA 125CA 15-3CA 19-9Carcinoembryonic Antigen (CEA) Gastrin Prostatic Acid Phosphatase (PAP)Prostate Specific Antigen, Free (FPSA)Prostate Specific Antigen, Total (TPSA)

Reproductive/Fertility Tests17-alpha-OH-progesteroneAlpha-fetoproteinEstradiolFollicle Stimulating Hormone (FSH)Human Chorionic Gonadotropin (hCG)Beta Human Chorionic Gonadotropin (β-hCG)Leuteinizing Hormone (LH)ProgesteroneProlactinTestosterone

Endocrine/Hormone TestsAldosteroneCalcitonin*CortisolDHEA SulfateGrowth HormoneInsulin*

Cardiac TestsHomocysteine

Anemia/Iron Deficiency TestsFerritin Folate (vitamin B9)Vitamin B12

Allergy TestsImmunoglobulin E (IgE)

Analytes

Thermo Scientific MASOmni Consolidated Controls

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Streamline your workflow Consolidate multiple QC products

competitor controls to8 Omni

Controls3Immunoassay Control

Specialty IA Control

Tumor Marker Control

Cardiac Marker Control

D-Dimer Control

Chemistry Control

Immunology Control

Rheumatoid Factor Control

Omni•IMMUNE™ or

Omni•IMMUNE PRO™

Omni•CORE™

Omni•CARDIO™

Value assignment for Omni Controls*Target values are provided for the key integrated instrument platforms available in the market place.

System Omni•IMMUNE™ & Omni•IMMUNE PRO™

Omni•CARDIO™ Omni•CORE™

Thermo Scientific Indiko™ Abbott Alinity™ Abbott Architect™ Beckman Coulter Access™ Beckman Coulter AU™ Beckman Coulter UniCel™ Beckman Coulter Synchron™ Ortho Clinical Diagnostics Vitros™ Roche Cobas™ Roche Elecsys™ Siemens Advia™ Siemens Atellica™ Siemens Centaur™ Siemens Dimension™ Siemens Dimension Vista™ Siemens Immulite™ Siemens Stratus™

* Includes Rilibäk support

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Part Number Level Bottles & Size Storage & Stability* MatrixCHA-1 1

6 x 5 mL Assayed 30 month shelf life @ -25 to -15 ºC

from date of manufacture14 days open-vial @ 2 to 8 ºC; unassayed 7 days open-vial @ 2 to 8 ºC; assayed

Human Serum

CHA-2 2CHA-3 3CHU-1 1

10 x 15 mL Unassayed

CHU-2 2CHU-3 3

MAS chemTRAK™•H This is a comprehensive multi-analyte control, designed to monitor general chemistry and TDM methods. Available in an assayed or unassayed format. Both formats are liquid, ready-to-use and no additional preparation is required. Assayed values are available for most major platforms.

AcetaminophenAlanine Aminotransferase (ALT)AlbuminAlkaline PhosphataseAmikacinAmylaseAmylase (Pancreatic)Apolipoprotein AApolipoprotein BAspartate Aminotransferase (AST)Bilirubin UnconjugatedBilirubin, ConjugatedBilirubin, Direct (DBIL)Bilirubin, NeonatalBilirubin, Total (TBIL)Blood Urea Nitrogen (BUN)C3 Complement*C4 Complement*CaffeineCalciumCarbamazepine

Analytes

Carbon Dioxide (CO2)ChlorideCholesterolCreatine Kinase (CK)CreatinineDigoxinDisopyramideEthanolEthosuximideFerritin*Gamma-Glutamyl TransferaseGentamicinGLDH*GlucoseHaptoglobin*HBDH*HDL CholesterolImmunoglobulin A (IgA)*Immunoglobulin G (IgG)*Immunoglobulin M (IgM)*Iron

Iron Binding Capacity, Total (TIBC)Iron Binding Capacity, Unsaturated (UIBC)*Lactate Dehydrogenase (LD)Lactic AcidLDL CholesterolLidocaineLipaseLipoprotein (a) LithiumMagnesiumMethotrexateN-acetylprocainamide (NAPA)OsmolalityPhenobarbitalPhenytoinPhosphorusPotassiumPrealbuminPrimidoneProcainamide

PseudocholinesteraseQuinidineSalicylateSodiumTheophyllineThyroid Stimulating HormoneThyroid Uptake (T-Uptake)Thyroxine, Free (FT4)*Thyroxine, Total (TT4)TobramycinTotal ProteinTransferrin*Tricyclic AntidepressantsTriglyceridesTriiodthyronine, Free (FT3)*Triiodthyronine, Total (TT3)*Uric AcidValproic AcidVancomycin

Thermo Scientific MASSerum Chemistry Controls

* These constituent levels have not been adjusted but are at levels found in the source material used in preparation of the controls. No claim is made for expected values of these constituents.

Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

Dropper Tips - Pkg 100 - MAS P/N 286-606

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MAS Alcohol/Ammonia

An assayed, bi-level control for monitoring ethanol and ammonia levels in serum. This ready-to-use product is packed in convenient multipacks and has been assayed for most major instruments. Normal Ammonia values in Level 1.

Part Number Level Bottles & Size Storage & Stability Matrix

AAC-MPBi-level,

Multi-Pack6 x 3.5 mL

24 month shelf life @ 2 to 8 ºC

from date of manufacture30 days open-vial @ 2 to 8 ºC

Human Serum

Ammonia Ethanol

Analytes

Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

Dropper Tips - Pkg 100 - MAS P/N 286-606

Bilirubin, ConjugatedBilirubin, Direct (DBIL) Bilirubin, Neonatal Bilirubin, Total (TBIL) Bilirubin, Unconjugated

AnalytesThis assayed, tri-level control has been designed to monitor the performance of total, direct, conjugated, unconjugated and neonatal bilirubin. There are no additional preparation steps required for this liquid, ready-to-use product. An elevated Bilirubin is included in level 3 for neonatal applications.

MAS Bilirubin

Part Number Level Bottles & Size Storage & Stability MatrixBC101 1

6 x 5 mL

24 month shelf life @ 2 to 8 ºC from date of manufacture

14 days open-vial @ 2 to 8 ºC when stored in the dark

Bovine SerumBC102 2

BC103 3

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Analytes

BilirubinBloodCreatinineCrystalsGlucoseHuman Chorionic Gonadotropin (hCG)KetonesLeukocyte EsteraseMicroalbuminNitrite

OsmolalitypHPotassiumProteinProtein-to-creatinine ratioRed Blood CellsSodiumSpecific GravityUrobilinogenWhite Blood Cells

MAS UA ControlA bi-level control that is liquid and ready-to-use with improved room temperature storage capability. This urine control was designed for monitoring urine dipstick and microscopic components and is assayed for most major reagent strips and strip systems. It includes ten commonly tested dipstick tests plus Microalbumin, Creatinine and hCG.

Part Number Level Bottles & Size Storage & Stability Matrix

UAB-115 1 (normal)

6 x 15 mL 24 month shelf life @ 2 to 8 ºC

from date of manufactureOpen Vial:

Refrigerated 3 months @ 2 to 8 °C

Room temperature 6 weeks @ 18 to 25 °C

Human Urine

UAB-160 4 x 60 mLUAB-215 2

(abnormal)6 x 15 mL

UAB-260 4 x 60 mL

UAB-MPBi-level,

Multi-Pack6 x 15 mL

MAS UA DipTubeMAS UA product packed into convenient dip tubes to simplify manual testing of urinalysis strips.

Part Number Level Bottles & Size Storage & Stability Matrix

UAT-MPBi-level,

Multi-Pack10 x 12 mL

24 month shelf life @ 2 to 8 ºC

from date of manufactureOpen Vial:

Refrigerated 8 weeks or 20 dips @ 2 to 8 ºC

Room temp 2 weeks or 10 dips @ 18 to 30 ºC

Human Urine

Analytes

BilirubinBloodCreatinineCrystalsGlucoseHuman Chorionic Gonadotropin (hCG)KetonesLeukocyte EsteraseMicroalbuminNitrite

OsmolalitypHPotassiumProteinProtein-to-creatinine ratioRed Blood CellsSodiumSpecific GravityUrobilinogenWhite Blood Cells

Analytes

BilirubinBloodCreatinineCrystalsGlucoseHuman Chorionic Gonadotropin (hCG)KetonesLeukocyte EsteraseMicroalbuminNitrite

OsmolalitypHPotassiumProtein Red Blood CellsSodiumSpecific GravityUrobilinogenWhite Blood Cells

MAS Urinalysis A bi-level urine control designed for monitoring urine dipstick and microscopic components. This liquid control is assayed for most major reagent strips and strip systems.

Part Number Level Bottles & Size Storage & Stability Matrix

0242221

(abnormal)

4 x 15 mL 12 month shelf life @ 2 to 8 ºC

from date of manufacture30 days open-vial @ 2 to 8 ºC

Human Urine024225 4 x 60 mL

0242243

(normal)

4 x 15 mL 18 month shelf life @ 2 to 8 ºC

from date of manufacture 30 days open-vial @ 2 to 8 ºC024227 4 x 60 mL

Thermo Scientific MASUrine Chemistry Controls

Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

Dropper Tips - Pkg 100 - MAS P/N 286-606

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Part Number Level Bottles & Size Storage & Stability Matrix

UR11001 1

6 x 15 mL24 month shelf life @ 2 to 8 ºC

from date of manufactureHuman Urine

UR22002 2

UR-MPBi-level,

Multi-Pack

MAS UrichemTRAKUrichemTRAK™ is designed to quantitatively monitor the most commonly tested urine chemistry analytes. This liquid, assayed control is ready-to-use, requires no additional preparation and the non-azide formulation will not interfere with ISEs. It includes general chemistry, physical properties and hCG tests.

Analytes

AmylaseCalciumChlorideCortisolCreatinineGlucoseHuman Chorionic Gonadotropin (hCG)MagnesiumMicroalbuminOsmolality

pHPhosphorusPotassiumSodiumSpecific GravityTotal ProteinUrea NitrogenUric Acid

Part Number Level Bottles & Size Storage & Stability Matrix

URN5005Bi-level,

Multi-Pack4 x 25 mL

18 months shelf life 2 to 8 ºC

from date of manufacture12 months open-vial @ room temperature

Synthetic

Sentry Urine Dipstick Control*Ideal for use outside the clinical laboratory where refrigerated storage isn’t always available. The Sentry Urine Dipstick Control offers 12 months room temperature stability for an immediate, ready to use urinalysis strip control. Suitable for Mutistix, Chemstrips, Diascreen and other urinalysis strips as well as automated strip readers. Supplied in two levels, normal and abnormal.

Analytes

BilirubinBloodGlucoseHuman Chorionic Gonadotropin (hCG)LeukocytesKetones

MicroalbuminNitritepHProteinSpecific GravityUrobilinogen

* Product is not CE marked and is available for sale outside the US.Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

Dropper Tips - Pkg 100 - MAS P/N 286-606

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Part Number Level Bottles & Size Storage & Stability MatrixLIG-101 1

6 x 5 mL

60 month shelf life @ -25 to -15 ºC

from date of manufacture90 days unopened @ 2 to 8 ºC 30 days open-vial @ 2 to 8 ºC

Human SerumLIG-202 2

LIG-303 3

MAS Liquimmune™ Save time and extra costs associated with lot changes using the MAS Liquimmune controls now with an extended shelf life. This multi-analyte immunoassay control is liquid based and designed to monitor immunoassay test procedures on automated instruments. Provides coverage of fertility, thyroid, iron deficiency, endocrine and allergy parameters. Assayed values are provided for major instrument systems.

Thermo Scientific MASImmunoassay Controls

Analytes

17-a-OH-ProgesteroneAcetaminophenAldosteroneAlpha-Fetoprotein (AFP)AmikacinCarbamazepineCarcinoembryonic Antigen (CEA)CK-MB (activity)CK-MB (mass) CortisolDHEA-SulfateDigoxinDisopyramideEstradiol

EthosuximideFerritinFolateFollicle Stimulating Hormone (FSH)GentamicinHomocysteineHuman Chorionic Gonadotropin (beta-hCG)Human Chorionic Gonadotropin (hCG)Human Growth HormoneImmunoglobulin A (IgA)*Immunoglobulin E (IgE)Immunoglobulin G (IgG)*Immunoglobulin M (IgM)*Insulin

LidocaineLithiumLuteinizing Hormone (LH)N-acetylprocainamide (NAPA)PhenobarbitalPhenytoinPrimidoneProcainamideProgesteroneProlactinProstate Specific Antigen, Total (TPSA)Prostate Specific Antigen, Free (FPSA)QuinidineSalicylate

TestosteroneTheophyllineThyroglobulinThyroid Stimulating Hormone (TSH)Thyroid Uptake (T-Uptake)Thyroxine, Free (FT4)Thyroxine, Total (TT4)TobramycinTricyclic AntidepressantsTriiodthyronine, Free (FT3)Triiodthyronine, Total (TT3)Valproic AcidVancomycinVitamin B12

* These constituent levels have not been adjusted but are at levels found in the source material used in preparation of the controls. No claim is made for expected values of these constituents.

Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

Dropper Tips - Pkg 100 - MAS P/N 286-606

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Part Number Level Bottles

& Size Storage & Stability Matrix

PTD1-1001 16 x 5 mL

36 month shelf life @ 2 to 8 ºC

from date of manufacture 30 days open-vial @ 2 to 8 ºC

Bovine Serum

PTD2-2002 2PTD3-3003 3

MAS PAR TDM This liquid therapeutic drug control is a multi-analyte control with assayed values designed for therapeutic drugs and common immunoassay test procedures on most automated instruments. No additional preparation is required for this liquid, ready-to-use product that offers three significant levels.

Part Number Level Bottles

& Size Storage & Stability Matrix

TUM-101 1

6 x 3 mL

36 month shelf life @ -25 to -15 ºC from date of manufacture

90 days unopened @ 2 to 8 ºC30 days open-vial @ 2 to 8 ºC

Human Serum

TUM-202 2

TUM-303 3

MAS T-Marker This liquid, assayed, multi-analyte control is designed to monitor performance of various cancer antigen tests on automated instruments, such as Abbott Architect™, Beckman Access/Dxl™, Ortho Vitros ECi™, Roche Modular Elecsys™, Siemens Advia Centaur™ and Immulite™, and Tosoh AIA 600II™. No additional preparation steps are required for these ready-to-use products.

Analytes

AcetaminophenAmikacinCaffeineCarbamazepineDigoxinDisopyramideEstriolEthanolEthosuximideGentamicinLidocaineLithiumMethotrexateN-acetylprocainamide (NAPA)

PhenobarbitalPhenytoinPrimidoneProcainamideQuinidineSalicylateTheophyllineThyroid Stimulating Hormone (TSH)Thyroxine, Total (TT4)TobramycinTricyclic AntidepressantsTriiodthyronine, Total (TT3)Valproic AcidVancomycin

Analytes

ACTH*AldosteroneAlpha-Fetoprotein (AFP)Beta Human Chorionic Gonadotroopin (beta-hCG)Beta-2-MicroglobulinCA 125CA 15-3CA 19-9CA 27-29CA 72-4CalcitoninCarcinoembryonic Antigen (CEA)CortisolCyFRA 21-1*

EstradiolFerritinGastrinHuman Chorionic Gonadotroopin (hCG)InsulinNSE*ProlactinProstate Specific Antigen, Total (TPSA)Prostate Specific Antigen, Free (FPSA)Prostatic Acid Phosphatase (PAP)Thyroglobulin* Not cleared by FDA. These constituent levels have not been adjusted but are at levels

found in the source material used in preparation of the controls. No claim is made for expected values of these constituents.

Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

Dropper Tips - Pkg 100 - MAS P/N 286-606

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Thermo Scientific MASCardiac & Diabetes Controls

Part Number Level Bottles

& Size Storage & Stability Matrix

CAI-XLL L

6 x 3 mL

36 month shelf life @ -25 to -15 °C

from date of manufacture30 days open-vial @ 2 to 8 °C (for hsCRP,

Digitoxin, Troponin I and Homocysteine)15 days open-vial @ 2 to 8 °C

for BNP32, Myoglobin (when a dropper tip is used), NT-proBNP, Troponin T, CK-MB

Human Serum

CAI-XL1 1CAI-XL2 2CAI-XL3 3

CAI-XL4Tri-level

Multi-Pack

MAS CardioImmune™•XLThis multi-analyte control is designed to monitor serum cardiac marker test methods. No additional preparation is required for this liquid, ready-to-use product. It offers four distinct levels, and is also available in a tri-level multipack.

Analytes

BNP 32CK-MBDigitoxinHomocysteineC-Reactive Protein high sensitivity (hs-CRP)MyoglobinNT-pro BNPTroponin ITroponin T

Part Number Level Bottles

& Size Storage & Stability Matrix

DBCL-MPBi-level

Multi-Pack6 x 1 mL

24 month shelf life @ -25 to -15 ºC

from date of manufacture60 days unopened @ 2 to 8 °C30 days open-vial @ 2 to 8 ºC

Human Whole Blood

MAS DiabetesThis liquid assayed diabetes control is a bi-level control designed to monitor hemoglobin A1c methods. Assayed for most major instrument systems. The liquid, ready-to-use product requires no additional preparation.

Analytes

Hemoglobin A1c (HbA1c)

Part Number Level Bottles

& Size Storage & Stability Matrix

CAI-UL UL 6 x 3 mL36 month shelf life @ -25 to -15 ºC

from date of manufacture30 days open-vial @ 2 to 8 ºC

Human Serum

MAS CardioImmune™ Ultra LowA single analyte control designed to challenge the low end sensitivity of the next generation high sensitivity Troponin assays. Analytes

Troponin I

Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

Dropper Tips - Pkg 100 - MAS P/N 286-606

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Part Number Level Bottles

& Size Storage & Stability Matrix

IC-101 1

6 x 3 mL24 month shelf life @ 2 to 8 ºC

from date of manufacture30 days open-vial @ 2 to 8 ºC

Human Serum

IC-202 2

IC-303 3

MAS ImmunologyThis multi-analyte immunology liquid assayed control is designed to monitor the performance of various serum protein and serology test procedures including Antistreptolysin O, C-Reactive Protein, Prealbumin and Rheumatoid Factor. It is assayed for major instrument systems and is ready-to-use, requiring no additional preparation. Three levels provide monitoring of the full assay range.

Analytes

AlbuminAlpha-1-AntitrypsinAlpha-2-MacroglobulinAntistreptolysin OAntithrombin IIIApha-1-Acid-GlycoproteinApolipoprotein A-1*Apolipoprotein B*Beta-2-MicroglobulinC-Reactive Protein (CRP)C3 ComplementC4 ComplementCeruloplasmin

Ferritin*HaptoglobinImmunoglobulin A (IgA)Immunoglobulin E (IgE)Immunoglobulin G (IgG)Immunoglobulin M (IgM)Kappa Light ChainLambda Light ChainPrealbuminProperdin Factor BRheumatoid Factor (RF)Total ProteinTransferrin

MAS CSFThis assayed, bi-level control is designed to monitor the performance of quantitative and manual chemical analysis of human cerebrospinal fluid. Multiple oligoclonal bands are present in Level 2. Assayed for major instrument systems as well as for cellulose acetate and agarose gel electrophoresis. These products are liquid, ready-to-use and require no additional preparation.

Part Number Level Bottles

& Size Storage & Stability Matrix

CSF-MPBi-level,

Multi-Pack6 x 3.5 mL

24 month shelf life @ 2 to 8 ºC

from date of manufacture30 days open-vial @ 2 to 8 ºC

Human Serum

Analytes

AlbuminChlorideGlucoseGlutamineImmunoglobulin A (IgA)*Immunoglobulin G (IgG)*Immunoglobulin M (IgM)*

Lactate Dehydrogenase (LDH)Lactic AcidPotassiumPrealbuminSodiumTotal Protein

Thermo Scientific MASImmunology & Protein Controls

* These constituent levels have not been adjusted but are at levels found in the source material used in preparation of the controls. No claim is made for expected values of these constituents.

Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

Dropper Tips - Pkg 100 - MAS P/N 286-606

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Part Number Level Bottles & Size Storage & Stability MatrixDOAT-1 1

6 x 18 mL 24 month shelf life @ 2 to 8 ºC

from date of manufacture 30 days open vial @ 2 to 8 ºC

Human Urine

DOAT-2 2DOAT-3 3DOAT-4 4DOAT-5 5DOAT-6 6

DOAT-MP Multi Pack1 bottle per level,

18 mL each

Part Number Level Bottles & Size Storage & Stability Matrix

10011608Multi-Pack

3 levels 6 x 5 mL

24 month shelf life @ 2 to 8 ºC

from date of manufacture 20 days open vial @ 2 to 8 ºC

Bovine Plasma

MAS TOX ControlThis multi-analyte control is developed for use with the Thermo Scientific MAS Toxicology immunoassays for the semi-quantitative measurement of barbiturates, benzodiazepine, and tricyclic antidepressants in either serum or plasma.

Analytes

Analytes

Barbiturate (Secobarbital)Benzodiazepine (Diazepam)Tricyclic Antidepressants (Nortriptyline)

(for use with DRI Serum Tox Reagents)

11-nor-9-COOH-D9-THCBenzoylecgonineBuprenorphineCotinined-MethamphetamineEDDPEthanolEthyl GlucuronideLSDMethadone

MethaqualoneMorphine, freeNitrazepamNortriptylineOxazepamOxycodonePhencyclidinePropoxypheneSecobarbital

Thermo Scientific MASToxicology Controls

* Substance Abuse and Mental Health Services Administration (SAMHSA) www.samhsa.gov

Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

Dropper Tips - Pkg 100 - MAS P/N 286-606

MAS DOA TOTAL™

This multi-constituent urine toxicology control offers 19 analytes with 4 distinct levels at drug concentrations 25% below and above commonly used screening and SAMHSA* cutoffs. A drug-free level and high positive level are also available (6 levels total). The control is a liquid, ready-to-use product available for use on a variety of instrument platforms. Each level of control is individually packed which gives you the flexibility to choose your levels according to your drug screen panel cutoffs while keeping the number of control vials to a minimum.

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Part Number Level Bottles & Size Storage & Stability Matrix

10014443Bi-level,

Multi-Pack6 x 2 mL

24 month shelf life @ 2 to 8 ºC

from date of manufacture 7 days onboard instrument

Human Serum

Part Number Level Bottles & Size Storage & Stability Matrix10014179 L

6 x 2 mL36 month shelf life @ -25 to -15 ºC

from date of manufacture 7 days onboard instrument

Human Serum10014180 110014181 210014182 3

Designed for use with the Siemens Dimension Vista instrumentationThermo Scientific™ MAS™ quality control products are available in vials specifically designed for use with the Siemens Dimension Vista™ instrumentation. Fully validated onboard QC stability claims provide assurance that long-term quality assurance is maintained when performing routine quality control on the Dimension Vista instrument.

Nine individual Thermo Scientific MAS quality control products are available in a Dimension Vista specific format covering the instrument assay portfolio. Six vials are provided in each kit for convenience.

MAS Alcohol/Ammonia

MAS CardioImmune™•XL

Quality Control Solutions for Vista

Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

Part Number Level Bottles & Size Storage & Stability Matrix

DBCL-VBi-level

Multi-Pack6 x 2 mL

24 month shelf life @ -25 to -15 ºC from date of manufacture

7 days onboard instrument

Human Whole Blood

Ammonia Ethanol

Analytes

Analytes

C-Reactive Protein high sensitivity (hsCRP)CK-MBDigitoxinHomocysteineMyoglobinNT-pro BNPTroponin I

Analytes

Hemoglobin A1c (HbA1c)

MAS Diabetes

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18

Part Number Level Bottles & Size Storage & Stability Matrix10014150 1

6 x 2 mLAssayed

30 month shelf life @ -25 to -15 ºC from date of manufacture 7 days onboard instrument

Human Serum10014151 210014152 3

MAS chemTRAK™•H

Analytes

AcetaminophenAlanine Aminotransferase (ALT)AlbuminAlkaline PhosphataseAmylaseApolipoprotein AApolipoprotein BAspartate Aminotransferase (AST)Bilirubin Direct (DBIL)Bilirubin Total (TBIL)Blood Urea Nitrogen (BUN)C3 Complement*C4 Complement*CalciumCarbamazepineCarbon Dioxide (CO2)ChlorideCholesterolCreatine Kinase (CK)CreatinineDigoxinEthanolFerritin*

Gamma-Glutamyl Transferase (GGT)GentamicinGlucoseHaptoglobinHDL CholesterolImmunoglobulin A (IgA)*Immunoglobulin G (IgG)*Immunoglobulin M (IgM)*IronIron Binding Capacity, Total (TIBC)Lactate Dehydrogenase (LD)Lactic AcidLDL CholesterolLidocaineLipaseLithiumMagnesiumN-acetylprocainamide (NAPA)PhenobarbitalPhenytoinPhosphorusPotassiumPrealbumin

ProcainamidePseudocholinesteraseSalicylateSodiumTheophyllineThyroid Stimulating Hormone (TSH)Thyroid Uptake (T-Uptake)Thyroxine, Free (FT4)*Thyroxine, Total (TT4)TobramycinTotal ProteinTransferrin*Tricyclic AntidepressantsTriglyceridesTriiodthyronine, Free (FT3)*Triiodthyronine, Total (TT3)*Uric AcidValproic AcidVancomycin

Part Number Level Bottles & Size Storage & Stability Matrix

10014444Bi-level,

Multi-Pack6 x 2 mL

24 month shelf life @ 2 to 8 ºC

from date of manufacture 7 days onboard instrument

Human Serum

MAS CSF

Analytes

AlbuminChlorideGlucose

Immunoglobulin A (IgA)*Immunoglobulin G (IgG)*Immunoglobulin M (IgM)*

Lactate Dehydrogenase (LD)Lactic Acid Potassium

PrealbuminSodiumTotal Protein

Part Number Level Bottles & Size Storage & Stability MatrixIC-V1 1

6 x 2 mL24 month shelf life @ 2 to 8 ºC

from date of manufacture 7 days onboard instrument

Human SerumIC-V2 2IC-V3 3

MAS Immunology

Analytes

AlbuminAlpha-1-Acid-GlycoproteinAlpha-1-AntitrypsinAlpha-2-MacroglobulinAntistreptolysin O (ASO)Apolipoprotein A1*

Apolipoprotein B*Beta-2-MicroglobulinC-Reactive Protein (CRP)C3 ComplementC4 ComplementCeruloplasmin

Ferritin*HaptoglobinImmunoglobulin A (IgA)Immunoglobulin E (IgE)Immunoglobulin G (IgG)Immunoglobulin M (IgM)

Kappa Light ChainLambda Light ChainPrealbuminRheumatoid Factor (RF)Total ProteinTransferrin

Thermo Scientific MASQuality Control Solutions for Vista

* These constituent levels have not been adjusted but are at levels found in the source material used in preparation of the controls. No claim is made for expected values of these constituents.Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

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Part Number Level Bottles & Size Storage & Stability Matrix10013876 1

6 x 2 mL60 month shelf life @ -25 to -15 ºC

from date of manufacture7 days onboard instrument

Human Serum10013877 210013878 3

MAS Liquimmune™

Part Number Level Bottles & Size Storage & Stability Matrix

10014127Bi-level,

Multi-Pack6 x 2 mL

24 month shelf life @ 2 to 8 ºC

from date of manufacture 7 days onboard instrument

Human Urine

MAS UrichemTRAK™

Analytes

AmylaseCalciumChlorideCortisol

CreatinineGlucoseMagnesiumMicroalbumin

PhosphorusPotassiumSodium

Total ProteinUrea NitrogenUric Acid

Analytes

AcetaminophenAlpha-Fetoprotein (AFP)CarbamazepineCarcinoembryonic Antigen (CEA)CK-MB (activity)CK-MB (mass) DigoxinEstradiolFerritinFolateFolate Stimulating Hormone (FSH)

GentamicinHomocysteineHuman Chorionic Gonadotropin (beta-HCG)Immunoglobulin A (IgA)Immunoglobulin E (IgE)Immunoglobulin G (IgG)Immunoglobulin M (IgM)LidocaineLithiumLutenizing Hormone (LH)N-acetylprocainamide (NAPA)

PhenobarbitalPhenytoinProcainamideProlactinProstate Specific Antigen (PSA)Prostate Specific Antigen Free (FPSA)SalicylateTestosteroneTheophyllineThyroid Stimulating Hormone (TSH)Thyroid Uptake (T-Uptake)

Thyroxine, Free (FT4)Thyroxine, Total (TT4)TobramycinTricyclic AntidepressantsTriiodthyronine, Free (FT3)Triiodthyronine, Total (TT3)Valproic AcidVancomycinVitamin B12

* These constituent levels have not been adjusted but are at levels found in the source material used in preparation of the controls. No claim is made for expected values of these constituents.Refer to package insert for specific analyte, stability claims, and limitations of procedures. Shelf life starts from the date of manufacture. Availability of products in each country depends on local regulatory marketing authorization status.

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Truly Real-Time Peer Comparison SoftwarePeer data is updated instantly

Daily QC Integration for MAS and Other QC ProductsAll your QC products are in one place

Simple and Intuitive InterfaceInteractive Levey-Jennings charts, Westgard rules, and audit-friendly reports

Automated QC Data TransferWith select systems

Cloud-BasedSSL encrypted. Automatically receive future updates

Smartify your labSave time and improve efficiency in your lab with Thermo Scientific LabLink xL Quality AssuranceMonitor your internal quality control while comparing results with other labs around the globe in real-time with Thermo Scientific™ LabLink xL™ cloud-based quality assurance software.

No Submission Cutoff DatesReview data whenever you want

Sigma Score and Other Performance Metrics%Bias, SDI, CVI, Z score, and more

Multiple Lab ManagementScalable software grows with your organization

Validated SoftwareFDA and GAMP 5 compliance

Multilingual CapabilitiesAvailable in 15+ languages

Thermo Scientific LabLink xLQuality Assurance Software

Truly Real-Time Peer Comparison SoftwarePeer data is updated instantly

Daily QC Integration for MAS and Other QC ProductsAll your QC products are in one place

Simple and Intuitive InterfaceInteractive Levey-Jennings charts, Westgard rules, and audit-friendly reports

Automated QC Data TransferWith select systems

Cloud-BasedSSL encrypted. Automatically receive future updates

Smartify your labSave time and improve efficiency in your lab with Thermo Scientific LabLink xL Quality AssuranceMonitor your internal quality control while comparing results with other labs around the globe in real-time with Thermo Scientific™ LabLink xL™ cloud-based quality assurance software.

No Submission Cutoff DatesReview data whenever you want

Sigma Score and Other Performance Metrics%Bias, SDI, CVI, Z score, and more

Multiple Lab ManagementScalable software grows with your organization

Validated SoftwareFDA and GAMP 5 compliance

Multilingual CapabilitiesAvailable in 15+ languages

Thermo Scientific LabLink xLQuality Assurance Software

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21

Day-to-day QC all in one place

• Perform all your daily QC activities inside LabLink xL with interactive charts and graphs

• Compare Levey-Jennings charts for multiple instruments

• Select Westgard and RiliBÄK violation rules

• Flag and comment on individual data points

Levey-Jennings Charts Westgard Sigma Rules

Compare your data with labs around the globe or just your affiliated

network

Determine if a worrisome result is an instrument problem, widespread issue, or

acceptable value

Peer data is updated in real-time, so you can identify trends and shifts sooner

Troubleshoot faster with real-time peer comparison

Day-to-day QC all in one place

• Perform all your daily QC activities inside LabLink xL with interactive charts and graphs

• Compare Levey-Jennings charts for multiple instruments

• Select Westgard and RiliBÄK violation rules

• Flag and comment on individual data points

Levey-Jennings Charts Westgard Sigma Rules

Compare your data with labs around the globe or just your affiliated

network

Determine if a worrisome result is an instrument problem, widespread issue, or

acceptable value

Peer data is updated in real-time, so you can identify trends and shifts sooner

Troubleshoot faster with real-time peer comparison

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22

Thermo Scientific LabLink xLQuality Assurance Software

Errors and Exceptions

Affliliated Exception Notes

Exception Notes

NEW IN LABLINK XL 2.0

Peer Data Comparison

Affiliated Lab

Condensed Interlab

Drugs of Abuse

Individual Lab

Instrument Interlab

Method Performance

Monthly Summary

Statistical Summary

Summary Urinalysis

Youden

Audit History

Audit

Point Data Submission

Summary Data Submission

Internal Performance

Comparison

Levey-Jennings

QC Summary

Region Specific

Rilibak Data Summary

Rilibak

• Easy-to-read reports help you monitor individual lab performance by shift, day and month

• View peer data alongside your laboratory data

Audit-friendly reports: Visualize data the way you want

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23

Audit-friendly reports: Visualize data the way you want

• No more manual data entry with fully automatic QC data transfer• QC results are uploaded to LabLink xL• Save time with error-free data submission and

increase confidence in results

LabLink xL Software

Auto-Connectivity Software

InstrumentLISMiddleware

Hands-free QC with Auto-Connectivity Software

Learn more about LabLink xL and Auto-Connectivity Software features and requirements maslablink.com

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24

Value assignment is an important requirement when rolling over to a new lot of QC material. The ability to provide full coverage of instrument target values involves the partnership of Thermo Fisher Scientific with laboratories performing the required testing. Without involvement of these external laboratories, the ability to provide value assignment coverage is significantly reduced.

Thermo Fisher Scientific is actively looking for new laboratories that are willing to assist with MAS™

QC Value Assignment in return for monetary compensation or free QC products. The results received from the participating laboratories are used to establish QC ranges in the lot specific package inserts for the MAS Quality Controls.

Testing Guidelines

• Each new lot of QC will utilize a different group of value assignment partner laboratories as participants are not required to test every QC lot.

• Advance notification of when to expect samples will be sent out prior to testing.

• Instructions for testing and data entry forms are sent with all value assignment samples.

• Most tests are run in duplicate over three separate days.

• All testing must to be completed within 4-6 weeks of receiving the samples.

Compensation Options

• Monetary: This is typically based upon a flat fee per data point plus reagent costs. As this varies between test systems and methods, there is no standard amount. The different reimbursement options will be discussed prior to product shipment.

• Free of charge MAS QC product: This is based upon the number of tests and MAS products being value assigned. Free QC product is given at the discretion of your sales representative. Further details will be provided by a member of the value assignment team.

Participation Requirements

• CLIA certification or equivalent local accreditation.

• A completed W-9 form (US only).

• A completed survey noting instruments and testing capabilities.

Steps to follow if you are interested in participating in the MAS Value Assignment Program

Step 1: Complete the form below.

Step 2: Fax this page to +1 510-771-1539 or e-mail to [email protected].

Step 3: A value assignment introduction pack will be sent via mail or e-mail. Please complete the forms and return to us.

Step 4: Once the introduction pack is received, a member of the value assignment team will notify you to discuss acceptance into the program and the different methods of compensation.

Lab Name:

Lab Address:

Contact Name: Alternate Contact:

Phone Number: Fax Number:

E-mail: Accreditation #:

Fax to: +1 510-771-1539

E-mail to: [email protected]

Thermo Scientific MASQC Value Assignment Program

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Analytes

Instruments

Order Placement

Technical Service & Support

Reference and Ordering

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26

References

17-OH-Progesterone u u u

25-OH-Vitamin D u u

Acetaminophen u u u u u u u

Acid Phosphatase n

Adrenocorticotropic Hormone u u n

Albumin (BCG) u u u u u u u

Albumin (BCP) u u u u

Aldosterone u u u

Alkaline Phosphatase (ALP) u u u

alpha-1- Acid Glycoprotein u u u

alpha-1-Antitrypsin u u u

alpha-2-Macroglobulin u u u

alpha-Fetoprotein (AFP) u u u u u

Aldosterone u u

Alanine Aminotransferase (ALT) u u u

Amikacin u u u u u u

Amitriptyline u n

Ammonia u u

Amphetamines u

Amylase u u u u u

Amylase (Pancreatic) u u

Antistreptolysin O (ASO) u u u

Anti-Thyroglobulin (anti-Tg) u

Anti-Thryroid Peroxidase (anti-TPO) u

Antithrombin III u

Apolipoprotein A1 u n u u n

Apolipoprotein B u n u u n

Appearance u u u

Aspartate Amonitransferase (AST) u u u

Barbiturates u u

Benzodiazepines u u

beta-2-Microglobulin u u u u u u

Human Chorionic Gonadotropin (beta-hCG) u u u u u u

Bile Acids u

Bilirubin, Conjugated u u u

Bilirubin, Direct u u u u

Bilirubin, Neonatal u u u

Bilirubin, Total u u u u

Bilirubin, Unconjugated u u u

Bilirubin, Urine u u u u

BNP 32 u u

Blood Urea Nitrogen (BUN) u u u

Buprenorphine u

Page 9 9 14 8 15 14 16 15 12 5 4 6 6 13 11 16 13 10 10 10 11 17 17 18 18 17 18 19 19

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u - Analyte present. n - No claim is made for expected values or the stability of these constituents.

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27

Page 9 9 14 8 15 14 16 15 12 5 4 6 6 13 11 16 13 10 10 10 11 17 17 18 18 17 18 19 19

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C-Peptide u u

C-Reactive Protein (CRP) u u u

C3 Complement u u u n u

C4 Complement u u u n u

CA 15-3 u u u

CA 19-9 u u u

CA 27-29 u

CA 72-4 u

CA 125 u u u

Caffeine u u u

Calcitonin n u

Calcium u u u u u

Cannabinoids (THC) u

Carbamazepine u u u u u u u u

Carbamazepine (Free) n

CEA (carcinoembryonic antigen) u u u u u

Ceruloplasmin u u u

Chloramphenicol u u

Chloride u u u u u u u

Cholesterol u u u

Creatine Kinase (CK) u u u u

CK-MB u u u u u

Carbon Dioxide (CO2) u u u

Cocaine (Benzoylecgonine) u

Color u u u

Cortisol u u u u u u u

Cotinine u

Copper u

Creatinine u u u u u u u u

Crystals u u u

CYFRA 21-1 n

d-Dimer u

d-Methamphetamine u

Diazepam u

DHEA-Sulfate u u u

Digitoxin u u u

Digoxin u u u u u u u u

Disopyramide u u u u u u

EDDP (Methadone Metabolite) u

Estradiol u u u u u

Estriol u

Estriol (Free) u u

u - Analyte present. n - No claim is made for expected values or the stability of these constituents.

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28

References

Page 9 9 14 8 15 14 16 15 12 5 4 6 6 13 11 16 13 10 10 10 11 17 17 18 18 17 18 19 19

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Ethanol u u u u u u

Ethanol Ethyl Glucuronide (EtG) u

Ferritin n n u u u u u n n u

Folate (Vitamin B9) u u u u

Fructosamine n n

Follicle Stimulating Hormone (FSH) u u u u

Gastrin u u u

Gentamicin u u u u u u u u

Gamma-Glutamyl Transferase (GGT) u u u

Glucose u u u u u u u u u u u

Haptoglobin u u u u u

Human Chorionic Gonadotropin (hCG) u u u u u u u u u u

HDL Cholesterol u u u

Hemoglobin (Urine Test) u u u u

Hemoglobin A1c (HbA1c) u u

Homocysteine u u u u u u

hsC-Reactive Protein (hsCRP) u u u

Human Growth Hormone u u u

Imipramine u u

Immunoglobulin A (IgA) n n u n u n u u u

Immunoglobulin E (IgE) u n u u u u u

Immunoglobulin G (IgG) n n u n u n u u u

Immunoglobulin M (IgM) n n u n u n u u u

Insulin u n n u

IGF-1 (insulin-like growth factor 1) u u

Iron u u u

Iron Binding Capacity (IBC) u u u

Kappa Light Chain u u

Ketones u u u u

Lactic Acid u u u u u

Lambda Light Chain u u

Lactate Dehydrogenase (LD) u u u u u

LDL Cholesterol u u u

Leukocyte Esterase u u u u

Lidocaine u u u u u u u u

Lipase u u u

Lipoprotein (a) u u

Lithium u u u u u u u u

LSD u

Luteinizing Hormone (LH) u u u u

Magnesium u u u u u

Methadone u

Methaqualone u

Methotrexate u u u

Microalbumin u u u u u u

u - Analyte present. n - No claim is made for expected values or the stability of these constituents.

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29

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Morphine, Free u

Myoglobin u u u

Myueloperoxidase (MPO) u

N-acetylprocainamide (NAPA) u u u u u u u u

N-Terminal Brain Natriuretic Peptide (NT-proBNP) u

Nitrite u u u u

Nordiazepam u u u

Nortriptyline u u u u

NSE n

Opiates (Morphine, Free) u

Osmolality u u u u u u

Oxazepam u

Oxycodone u

Prostatic Acid Phosphatase (PAP) u u u

Parathyroid Hormone (PTH) u u

pH u u u u u

Phencyclidine (PCP) u

Phenobarbital u u u u u u u u

Phenytoin u u u u u u u u

Phenytoin (Free) u u

Phosphorus u u u u u

Potassium u u u u u u u u u u

Prealbumin u u u u u u u

Pregency Associated Plasma Protein (PAPP-A) n n

Primidone u u u u u u

NT-proBNP u u

Procalcitonin (PCT) u u u

Procainamide u u u u u u u u

Progesterone u u u

Prolactin u u u u

Properdin Factor B u u

Propoxyphene u

Protein Electrophoresis u

Prostate Specific Antigen, Total (TPSA) u u u u u

u - Analyte present. n - No claim is made for expected values or the stability of these constituents.

Page 30: Thermo Scientific MAS Quality Control Products LabLink xL ......Lipoprotein A (Lp(a))* Prealbumin ... CA 125 CA 15-3 CA 19-9 Carcinoembryonic Antigen (CEA) Gastrin Prostatic Acid Phosphatase

30

References

Page 9 9 14 8 15 14 16 15 12 5 4 6 6 13 11 16 13 10 10 10 11 17 17 18 18 17 18 19 19

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Prostate Specific Antigen, Free (FPSA) u u u u u

Pseudocholinesterase (PCHE) u u u

Quinidine u u u u u u

Red Cells (Urine Test) u u u

Rheumatoid Factor (RF) u u u

Salicylate u u u u u u u u

Secobarbital u u

Sex Hormone Binding Globulin (SHBG) u

Sodium u u u u u u u u u u

Specific Gravity u u u u u

Testosterone u u u u

Thyroid Uptake (T-Uptake) u u u u u u u

Triiodothyroxine, Total (TT3) n u u u n u

Triiodothyroxine, Free (FT3) n u u u n u

Thyroxine, Total (TT4) u u u u u u u

Thyroxine, Free (FT4) n u u u n u

TBG (Thyroxine-Binding Globulin) u u

Theophylline u u u u u u u u

Thyroglobulin u u u u

Iron Binding Capacity, Total (TIBC) u u

Tobramycin u u u u u u u u

Total Protein u u u u u u u u u u u u u

Transferrin u u u u

Tricyclic Antidepressants u u u u u u u u u

Triglycerides u u u

Troponin I u u u

Troponin T u u

Thyroid Stimulating Hormone (TSH) u u u u u u u u

Iron Binding Capacity, Unsaturated (UIBC) u u

Urea Nitrogen u u u u u

Uric Acid u u u u u

Urobilinogen u u u u

Valproic Acid u u u u u u u u

Valproic Acid Free u u

Vancomycin u u u u u u u u

Vitamin B12 u u u u

White Cells (Urine Test) u u u

Zinc u

u - Analyte present. n - No claim is made for expected values or the stability of these constituents.

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31

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ABBOTTAlinity u u u u u u u u u u u u u u u u

Architect u u u u u u u u u u u u u u u

ACON INTERNATIONALACON Mission (Visual) u u u

Mission U120 u u u

Mission U500 u u u

BECKMAN-COULTERAccess u u u u u u u u

AU Series u u u u u u u u u u u u

ICON u u

ICON/11/25/20 u u

Immage u u u u u

Synchron CX/LX u u u u u u u u u u u u

UniCel DxI u u u u u u u u

UniCel DxC Synchron u u u u u u u u u u u u

BIOLIS24i Clinical Systems u

BIOMERIEUXVidas Systems u u u u u

BIOVATIONBiovation u u u

BIORADDiaSTAT u

D-10 u

Variant/Variant II u

COLE TAYLOR MARKETING, INC. (VISUAL)Cole Taylor (on CT-120) u u

Cole Taylor (on Clinitek) u

DFI DIAGNOSTICSDFI ComboStik (Visual) u u

DFI ComboStik Series u u

DFI ComboStik CYBOW (Visual) u u

DFI ComboStick CYBOW Series u u

DFI 10 +/ DUS (Visual) u u

DFI DU Reader 300 u u

DFI DUS R-300 u u

ERBA DIAGNOSTICSERBA Urodip (Visual) u u

ERBA Urodipcheck 300 u u

u - Analyte present. n - No claim is made for expected values or the stability of these constituents.

Page 32: Thermo Scientific MAS Quality Control Products LabLink xL ......Lipoprotein A (Lp(a))* Prealbumin ... CA 125 CA 15-3 CA 19-9 Carcinoembryonic Antigen (CEA) Gastrin Prostatic Acid Phosphatase

32

References

FISHERBRANDSure-Vue u u u u

UriSystem u u u

Fisher Brand (Visual) u u u

Fisher Brand (on Clinitek) u u u

GENZYME CORPORATIONOSOM HcG Combo u u u u

Signify n n u u

CONTRAST II n n u

HYPOGUARDDiaScreen 10 (visual) u u u

DiaScreen 50 u u u

IRIS DIAGNOSTICSAution MAX AX-4280 u u u

Aution MAX IQ200 Combo u u u

Aution MAX AX-4280/JET u u

Aution Max AX-4030 u u u

Aution Eleven u u

iChem 100 u u u n

iQ200 u u u n

MACHEREY-NAGELURYXXON 300 u u

URYXXON Relax u u

ORTHO CLINICAL DIAGNOSTICSVitros u u u u u u u u u

Vitros ECi/3600 u u u u u u u

Vitros 5,1 FS u u u u u u u u u u

Vitros 4600/5600 u u u u u u u u u u u u u u

QUIDEL CORPORATIONQuickVue (visual) u u u

UrinQuick u u

ROCHECobas c/e modules u u u u u u u u u u u u u u

Chemstrip 101 u u u

Cobas Integra u u u u u u u u u u u

Criterion 1/11 u u u

CUA/SUA u u u

Elecsys u u u u u u

Hitachi/Modular Analytics E170 u u u u u u u u u u u u u u u u u

Micral u u u

Mini UA u u u

Reagent Strip (visual) u u u

Urisys 1800/2400/1100 u u

u - Analyte present. n - No claim is made for expected values or the stability of these constituents.

Page 9 9 14 8 15 14 16 15 12 5 4 6 6 13 11 16 13 10 10 10 11 17 17 18 18 17 18 19 19

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Page 33: Thermo Scientific MAS Quality Control Products LabLink xL ......Lipoprotein A (Lp(a))* Prealbumin ... CA 125 CA 15-3 CA 19-9 Carcinoembryonic Antigen (CEA) Gastrin Prostatic Acid Phosphatase

33

SIEMENS HEALTHCAREAcetest u u u

Advia 1650/2400 u u u u u u n u u u u

Advia Centaur u u u u u u

Atellica u u u u u u u u u u u u u u u u

Altas u u u

BNA u

BN II/Prospec u u u u n n u

Clinitek Series u u u

Clinitest u u u

DCA 2000/Vantage u n

Dimension Series u u u u u u u u u u u u u u u u u

Dimension VISTA u u u u u u u u u u u u u u u u u u u u u

Ictotest u u u

Immulite/Immulite 2000 u u u u u u u u

Micro-Bumintest u u u

Reagent Strip (visual) u u u

Status u u u

Stratus CS u u

Viva Systems u u

THERMO FISHER SCIENTIFICIndiko u u u

Konelab Systems u u u u

B·R·A·H·M·S KRYPTOR u u u u

MGC240 u u

TOSOH BIOSCIENCESAIA Series u u u u u u u

A1c 2.2 Plus u

G7/G8 u

YD DIAGNOSTICSUriscan (Visual) u u u

Uriscan Pro II u u u

Uriscan Optima II u u u

Uriscan Mini u

Uriscan Super u u

u - Analyte present. n - No claim is made for expected values or the stability of these constituents.

Page 9 9 14 8 15 14 16 15 12 5 4 6 6 13 11 16 13 10 10 10 11 17 17 18 18 17 18 19 19

Instrument

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Page 34: Thermo Scientific MAS Quality Control Products LabLink xL ......Lipoprotein A (Lp(a))* Prealbumin ... CA 125 CA 15-3 CA 19-9 Carcinoembryonic Antigen (CEA) Gastrin Prostatic Acid Phosphatase

34

References

Architect™ and Alinity™: Abbott Laboratories, Abbott Park, IL

Access™, AU™ Series, Immage™, CX/LX™, ICON™, ICON 11/25/20™, SYNCHRON™ UniCel Dxl™ and UniCel DxC™: Beckman Coulter Inc., Brea, CA

VIDAS™ Systems: bioMérieux

DiaSTAT™, D-10™ and Variant/Variant™ II: Bio-Rad Laboratories, Hercules, CA

Biovation™: Biovation Inc., Hercules, CA

Biolis 24i™ Clinical Chemistry Analyzer: Carolina Liquid Chemistries Corp.

DFI ComboStik™ (Visual), DFI ComboStik™ Series, DFI ComboStik™ CYBOW (Visual), DFI ComboStick™ CYBOW Series, DFI 10 +/ DUS (Visual), DFI DU Reader 300, DFI DUS R-300: DFI DIAGNOSTICS

SPAplus™: The Binding Site Group Ltd, Birmingham, UK

ERBA Urodip™ (Visual), ERBA Urodipcheck 300™: ERBA Diagnostics

Fisherbrand™, UriSystem™ and Sure-Vue™: Fisher Scientific, Pittsburgh, PA

CONTRAST II™, OSOM™ and Signify™: Genzyme Corp. Cambridge, MA

DiaScreen™ 10 and DiaScreen™ 50: Hypoguard, Minneapolis, MN

Aution™ MAX AX-4280, Aution™ MAX IQ200 Combo, Aution™ MAX AX-4280/JET, Aution™ Max AX-4030m, Aution™ Eleven, iChem100™ and IQ200™: International Remote Imaging Systems Inc., Chatsworth, CA

URYXXON® 300, URYXXON® Relax: MACHEREY-NAGEL Inc.

Vitros™, Vitros™ ECi, Vitros 5,1 FS and Vitros 5600™: Ortho Clinical Diagnostics, Rochester, NY

QuickVue™ and UrinQuick™: Quidel Corporation, San Diego, CA

Cobas™ c/e modules, Elecsys™, Hitachi™ Series, Cobas Integra™, Modular Analytics E170, Criterion 1/11™, CUA/SUA, MiniUA™, Chemstrip 101™, Urisys 1100/1800™, Urisys 2400 and Micral™: Roche Diagnostics, Indianapolis, IN

Advia Centaur™, Advia 1650/2400™, Atellica™, Atlas™, BNA/BN II™, BN ProSpec™, Clinitek Series™, Clinitest™, DCA 2000™, Dimension™, Dimension™ VISTA, Dimension™ Xpand, Ictotest™, Immulite™/Immulite™200, Microbumintest™, Status™ and Stratus™ CS: Siemens Healthcare Diagnostics, Los Angles, CA; Glasgow, DE; and Tarrytown, NY

AIA™ Series, A1c 2.2 Plus and G7/G8: Tosoh Medics Inc., S. San Francisco, CA

URiSCAN® (Visual), URiSCAN® Pro II, URiSCAN® Optima II, URiSCAN® Mini, URiSCAN® Super: YD Diagnostics Corp. Songpa-ku, Seoul, Korea

A1CNow™: PTS Diagnostics, Tarrytown, NY. Now owned and distributed by PTS Diagnostics, Sunnyvale, CA

OTHERArteray Monarini u

Bilirubinometer u u

Coverslip u u u

Diastix (Bayer) u u u

Emit u u u

Flame Photometer u u n u u u u

A1CNow u

Osmometer u u u

pH Meter u u

Refractometer u u u

Thermo Electron Pocketchem u u u

u - Analyte present. n - No claim is made for expected values or the stability of these constituents.

Page 9 9 14 8 15 14 16 15 12 5 4 6 6 13 11 16 13 10 10 10 11 17 17 18 18 17 18 19 19

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Page 35: Thermo Scientific MAS Quality Control Products LabLink xL ......Lipoprotein A (Lp(a))* Prealbumin ... CA 125 CA 15-3 CA 19-9 Carcinoembryonic Antigen (CEA) Gastrin Prostatic Acid Phosphatase

35

General Ordering Information

Order Placement Phone: 1-800-232-3342 - Press 1 for Customer Service.

Fax: 1-800-829-8115

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e-mail or Fax: Required - Please indicate the following information on your purchase order:

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Mail: Thermo Fisher Scientific 46500 Kato Road Fremont, CA 94538 USA ATTN: Customer Service

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Delivery: Domestic orders are shipped two-day air freight. International orders are shipped through a freight forwarder.

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Minimum Orders: We have a minimum order requirement of $100.

Minimum Dating Reference: Thermo Fisher Scientific currently follows a policy of shipping products to customers based on the shelf life of the product that exists at the time of shipping. Thermo Fisher Scientific does not guarantee the shelf life of the product that is stated in the catalog. The shelf life of the product is based on the date of manufacture and customers may receive products that are within the shelf life of the product and not the full shelf life of the product as advertised. We take all necessary precautions to ensure that our customers receive products with a minimum dating of 6 months.

Sales SupportPhone: 1-800-232-3342

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Phone: 1-800-232-3342- press 2 for technical service options

For non-urgent inquiries: e-mail: LabLink Support - [email protected] MAS - [email protected] CEDIA, DRI, QMS and Instrumentation - [email protected]

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NOTE: Sales are subject to the other terms and conditions on Thermo Fisher Scientific invoice. All sales are final. Returned products require a Return Materials Authorization and may be subject to a Restocking Fee. Call Thermo Fisher Scientific prior to returning any material.

Page 36: Thermo Scientific MAS Quality Control Products LabLink xL ......Lipoprotein A (Lp(a))* Prealbumin ... CA 125 CA 15-3 CA 19-9 Carcinoembryonic Antigen (CEA) Gastrin Prostatic Acid Phosphatase

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