product list - bioactiva · 2018. 7. 20. · herpesvirus type 7 dna 48, 96 ba036 human herpes virus...

Product ListMolecular Diagnostics2016 - 2017

Rev.1/2016

bioactiva 3 For electronic publication only

mdc medical device certification GmbH

Kriegerstraße 6

D-70191 Stuttgart, Germany

Phone: +49-(0)711-253597-0

Fax: +49-(0)711-253597-10

Internet: http://www.mdc-ce.de

mdc medical device certification GmbH certifies that

bioactiva diagnostica GmbH Louisenstraße 137

61348 Bad Homburg Germany

for the scope

development, manufacturing and distribution of in-vitro diagnostics; distribution of medical devices

has introduced and applies a

Quality Management System

The mdc audit has proven that this quality management system meets all requirements of the following standard

EN ISO 13485

Medical devices – Quality management systems – Requirements for regulatory purposes

(EN ISO 13485:2012 + AC:2012)

Valid from 2013-01-20 Valid until 2018-01-20

Registration no. 1090.58.21/0 Report no. E 1090.58 / 2012-12-06

Stuttgart 2012-12-06

Head of Certification Body

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1.1. Hepatitis Viruses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.2. Human Immunodeficiency Virus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 HIV-associated diseases

1.3. Human Papilloma Viruses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.4. Sexually Transmitted Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Combined Kits (Several Combination Tests)

1.5. Herpes Virus Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.6. Toxoplasma, Rubella, CMV, Herpes simplex (TORCH) Infections . . . . . . . . . . . 10

1.7. Respiratory Infections / Tuberculosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11 Respiratory Infections Tuberculosis and TB Resistance

1.8. Neurological Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Enterovirus / Poliovirus Meningititis

1.9. Gastrointestinal Infections / Parasites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13 Parasites / Protozoa Parasites / Helminths

1.10. Further Infectious Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

1.11. Tick Borne Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

1.12. Fungal and Yeast Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

1.13. Emerging Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-15 Viral diseases, hemorrhagic fevers Parasites

1.14. Bacteriology / Sepsis / Pyogenic Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

1.15. Bacterial Drug Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-16

1.16. Periodontitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

1.17. Biothreat Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

1. HUMAN PATHOGEN DETECTION & GENOTYPING

2.1. Oncogene Expression Quantification / Minimal Residual Disease (MRD) . . . . 16-19 Chronic Melogenous Leukaemia Acute Myelogenous / Acute Lymphatic Leukaemia Lymphoma CML / AML / ALL Translocation Screening Chimerism Detection in Leukemia Nephroblastoma Breast and Ovarian Cancer Cervical and Head-Neck Cancer Hepatocellular Cancer Lung Cancer Malignant Melanoma Soft Tissue Sarcoma and Bladder Cancer Reference Gene Transcripts / “Housekeeping Genes”

2.2. Somatic Mutation with Therapeutic Implications in Various Cancers . . . . . . 19

2. ONCOLOGY

Table of Contents Page

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3.1. Thrombophilia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19-20

3.2. Cardiovascular Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20-21 Hypertension Myocardial Infarction & Ischemic Stroke Lipid Metabolism

3.3. Diabetes and Obesity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

3.4. Pharmacogenetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-22 Anticoagulants Warfarin Resistance Coumarin Resistance Clopidogrel (Plavix) Resistance Tacrolimus (FK-506 or Fujimycin) Resistance Statins Resistance

3.5. Genetic diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-23 Muscular Dystrophy Fragile X Syndorme Chorea Huntington Cystic Fibrosis Haemochromatosis Osteoporosis Thalassemia / FMF Aneuploidies Lactose Intolerance Avellino Corneal Disease Genetic Polymorphisms Involved in Anti-Viral Treatment Male infertility

3. HUMAN GENETIC DISEASES AND GENETIC PREDISPOSITIONS

4.1. HLA / HPA Typing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-24 Narcoplepsia Morbus Behcet Celiac Disease (Gluten Intolerance) Rheumatoid Arthritis/ Ankylosing Spondylitis HPA Typing

4.2. Blood Group Typing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

4. HLA AND BLOOD GROUP TYPING

5.1. Identification of Meat Species in Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24-25

5.2. Genetically Modified Organisms (GMO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

5.3. Food Pathogens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25-26

5.4. Food Allergens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26-27

5.5. Concentration of Water Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

5.6. Concentration of Water Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

5. FOOD ANALYSIS


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7.1. DNA Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31-32

7.2. RNA Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

7. NUCLEIC ACIDS PURIFICATION

8.1. PCR /RT-PCR Enzymes & Mixes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

8.2. Reverse Transcription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

8.3. PCR Additives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

8.4. DNA Electrophoresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

8. PCR REAGENTS & ADDITIVES

6.1. Cattle / Ruminants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

6.2. Swine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

6.3. Poultry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28-29

6.4. Feline & Canine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

6.5. Equine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

6.6. Sheep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

6.7. Primates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

6.8. Honey Bee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

6.9. Animal-Related Mycoses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

6.10. Animal-Related Parasites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

6.11. Further Animal-Related Bacteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30-31

6.12. Further Animal-Related Virus Detection Assays . . . . . . . . . . . . . . . . . . . . . . . . 31

6. ANIMAL RELATED DISEASES / ZOONOSES

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9.1. Thermal Cycler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

9.2. Endpoint Fluorescence Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

9.3. DNA Electrophoresis / PCR Product Detection . . . . . . . . . . . . . . . . . . . . . . . . . 33

9.4. Real Time PCR Instruments & Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33-34

9.5. Automated Nucleic Acids Extraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

9.6. Automated Liquid Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

9.7. DNA Plot Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

9.8. ELISA Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

9.9. Pipettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

9.10. Incubators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

9.11. Thermoshaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

9.12. Centrifuges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

9.13. Safety Cabinets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35-36

9.14. Ovens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

9.15. Autoclaves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

9.14. Balances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

9. PCR LAB EQUIPMENT

10.1. PCR Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

10.2. Reaction Vessels / Reagent Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

10.3. Pipette Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37-38

10. CONSUMABLES FOR REAL-TIME PCR AND CONVENTIONAL PCR


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1. HUMAN PATHOGEN DETECTION & GENOTYPING

BA001 Hepatitis A RNA (HAV) RT-PCR Kit (one-step) Real Time PCR test for detection of HAV RNA (quantitative; with or without RNA Extraction) 50, 96

BA401 Hepatitis B DNA (HBV qual) PCR Kit Real Time PCR test for detection of HBV DNA (qualitative; with or without DNA Extraction) 48

BA002 Hepatitis B DNA (HBV quant) PCR Kit Real Time PCR test for detection of HBV DNA (quantitative; with or without DNA Extraction)

25, 48, 60, 96, 100, 120

BA402 Hepatitis C RNA (HCV qual) RT-PCR Kit (one-step)

Real Time PCR test for detection of HCV RNA (qualitative; with or without RNA Extraction) 24, 48

BA003 Hepatitis C RNA (HCV quant) RT-PCR Kit (one-step)

Real Time PCR test for detection of HCV RNA (quantitative; with or without RNA Extraction) 48, 60, 96, 100, 120

BA004 Hepatitis D RNA (HDV) RT-PCR Kit (one-step) Real Time PCR test for detection of HDV RNA (quantitative; with or without RNA Extraction) 50, 60, 96, 100, 120

BA005 Hepatitis E RNA (HEV) RT-PCR Kit (one-step) Real Time PCR test for detection of HEV RNA (quantitative; with or without RNA Extraction) 25, 32, 48, 50, 96

BA006 Hepatitis G RNA (HDV) RT-PCR Kit (one-step) Real Time PCR test for detection of HGV RNA (qualitative; with or without RNA Extraction) 25, 50

BA011 HBV Genotyping Kit Real Time PCR test test or PCR/reverse Line Blot test for detection of HBV DNA genotypes A-H 20, 50

BA008 HBV/HDV PCR Kit Multiplex Real Time PCR test for simultaneous detection of HBV and HDV RUO 100

BA012 HCV Genotyping Kit Real Time PCR test or PCR/reverse Line Blot test for detection of HCV RNA 1a,1b, 2, 3a, 4, 5a, 6 genotypes 20, 24, 48, 50

BA009 HCV/HBV/HIV PCR Kit Multiplex Real Time PCR test for simultaneous detection of HBV, HCV and HIV-1 RUO 100

BA010 HCV/HBV/HIV1/HIV2 PCR Kit Multiplex Real Time PCR test for simultaneous detection of HBV, HCV, HIV-1 and HIV-2 RUO 100

BA007 Transfusion-transmitted Virus (TTV) PCR Kit Real Time PCR test for detection of TTV (synonym: Torque Teno Virus) DNA, often found in patients with liver disease 25

Order number Product name Legal Status Tests/SizeIntended use

1.1 Hepatitis Viruses

BA013 Human Immuno-deficiency Virus (HIV-1) RT-PCR Kit (one-step)

Real Time PCR test for detection of HIV-1 RNA (quantitative; with or without RNA Extraction)

25, 48, 60, 96, 100, 120

BA014 Human Immuno-deficiency Virus (HIV-2) RT-PCR Kit (one-step)

Real Time PCR test for detection of HIV-2 RNA (quantitative; with or without RNA Extraction) RUO 25

1.2 Human Immunodeficiency Virus

BA015 Pneumocystis PCR Kit Real Time PCR test for detection and/or quantification of Pneumocystis jirovecii (carinii) DNA 48, 50, 96, 100

HIV-associated diseases

Order number Product name Legal Status Tests/SizeIntended use

BA403 High Risk HPV Genotyping PCR KitReal Time PCR test combined with Multi-Color Melting Curve Ana-lysis to identify the 14 high-risk HPV types, including HPV-16, 18, 31,33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68

48

BA018 Human Papilloma Virus (HPV) Detection and Differentiation PCR Kit

Amplification/Reverse hybridization assay for the differentiation of “high risk” and “low risk“ genotypes and the typing of HPV 16, 18, 45, 6, 11, 30s and 50s genotypes

12, 60

BA017 Human Papilloma Virus (HPV) High Risk Screen PCR Kit

Real Time PCR test for quantitative screening of ≥12 HPV (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) in 1 tube; with or without DNA Extraction

25, 60, 100

BA020 Human Papilloma Virus Genotyping PCR Kit Real Time PCR test or strip test for detection and genotyping of Low & High Risk HPV 20, 48, 96

1.3 Human Papilloma VirusesOrder number Product name Legal Status Tests/SizeIntended use

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BA033 Epstein-Barr Virus (EBV) PCR Kit Real-time PCR test for detection or quantification of EBV DNA in human blood or tissue samples

25, 48, 50, 60, 96, 100, 120

BA034 Human Herpes Virus 6 (HHV6) PCR Kit Real Time PCR test for detection of Human Herpesvirus type 6 DNA 25, 48, 50 96, 100

BA035 Human Herpes Virus 7 (HHV7) PCR Kit Real Time PCR test for detection and quantification of Human Herpesvirus type 7 DNA 48, 96

BA036 Human Herpes Virus 8 (HHV8) PCR Kit Real Time PCR test for detection and quantification of Human Herpesvirus type 8 DNA 25, 48, 96

BA037 Varicella Zoster Virus (VZV) PCR Kit Real Time PCR test for detection of VZV DNA 25, 48, 50, 96

1.5 Herpes Virus InfectionsOrder number Product name Legal Status Tests/SizeIntended use

BA032 Chlamydia trachomatis/ N. gonorrhoeae PCR Kit

Multiplex Real Time PCR test for detection of Chlamydia trachomatis and N. gonorrhoeae DNA 25, 48, 96 100

BA031 Chlamydia trachomatis/ Ureaplasma/ M. hominis PCR Kit

Multiplex Real Time PCR test for detection of Chlamydia trachomatis/ Ureaplasma/M. hominis DNA 48, 96 100

BA021 Bacterial Vaginosis PCR KitMultiplex Real Time PCR test for detection or quantification of G. vaginalis, Atopobium vaginae, Lactobacillus spp. and total bacteria in the vaginal biotope

100

BA022 Candidosis PCR Kits Real Time PCR test for quantitative detection of C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicansi DNA 100

BA023 Chlamydia PCR Kit Real Time PCR test for detection or quantification of Chlamydia trachomatis DNA 48, 50, 96, 100

BA404 CT/NG PCR Kit Multiplex Real Time PCR test for detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA 48, 96

BA024 Gardnerella PCR Kit Real Time PCR test for detection of Gardnerella vaginalis 100

BA405 Mycoplasma genitalium PCR Kit Real Time PCR test for detection of Mycoplasma genitalium genome by amplification of the B subunit of DNA gyrase gene. 50

BA406 Mycoplasma hominis PCR Kit Real Time PCR test for the identification of Mycoplasma hominis genome by amplification of the 16S rRNA gene. 50

BA025 Mycoplasma species PCR Kit Real Time PCR test for detection of Mycoplasma species (M. hominis, M. genitalis) DNA

48, 50, 55, 96, 100, 110

BA026 Neisseria PCR Kit Real Time PCR test or Amplification/Reverse hybridization assay for detection of Neisseria gonorrhoeae DNA 16, 25, 48, 96, 100

BA407 STD Panel PCR Kit (11 pathogens)Amplification/Reverse hybridization assay for detection of pathogens related to Sexual Transmitted Diseases, 11 pathogens (T. pallidum, C. trachomatis, N. gonorrhoeae, M. genitalium, T. vaginalis, U. parvum, U. urealyticum, M. hominis, H. simplex I, H. simplex II, L. venereum)

16

BA408 T. vaginalis/ N. gonorrhoeae/ Chl. Trachomatis PCR Kit

Multiplex Real Time PCR test for detection of T. vaginalis, N. gonorrhoeae and Chl. trachomatis DNA 100

BA028 Treponema PCR Kit Real Time PCR test for detection of Treponema pallidum DNA 100

BA029 Trichomonas PCR Kit Real Time PCR test for detection of Trichomonas vaginalis DNA 48, 96, 100

BA030 Ureaplasma species PCR Kit Real Time PCR test for detection of Ureaplasma species (U. parvum, U. urealyticum) DNA 48, 96, 100

BA409 Urethritis PCR Kit Multiplex Real Time PCR test for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium DNA 32

BA410 Vaginal Swab PCR Kit (6 pathogens)Multiplex Real Time PCR test for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, herpes simplex virus 1, 2, Treponema pallidum DNA

32

Combined kits (several combination tests)

1.4 Sexually transmitted diseasesOrder number Product name Legal Status Tests/SizeIntended use

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BA038 Herpes Simplex Virus 1 and/or 2 (HSV-1, HSV-2) PCR Kit

Real-time PCR test for detection of HSV-1 and/or HSV-2 DNA in human samples

25, 48, 60, 96, 100, 120

BA411 HSV 1/2 Typing PCR Kit Real-time PCR test for detection and typing of HSV DNA 100

BA412 HSV 1+2/VZV PCR Kit Multiplex Real Time PCR test for detection of Herpes Simplex Virus 1 and 2, and Varizella Zoster Virus DNA 96

BA039 Human Cytomegalovirus (HCMV) PCR KitReal-time PCR test for detection or quantification of human Cytomegalovirus (HCMV, CMV) DNA in human EDTA plasma or serum samples

25, 48, 50, 60, 96, 100, 120

BA040 Measles Virus RT-PCR Kit Real Time PCR test for detection of Measles Virus RNA RUO 150

BA041 Mumps Virus RT-PCR Kit Real Time PCR test for detection of Mumps Virus RNA RUO 150

BA042 Parvovirus B19 (PVB19) PCR Kit Real Time PCR test for detection or quantification of PVB19 DNA25, 48, 50, 60, 96, 120

BA043 Rubella PCR Kit Real Time PCR test for detection of Rubella DNA 50

BA044 Toxoplasma PCR Kit Real Time PCR test for detection of Toxoplasma DNA 50

1.6 Toxoplasma, Rubella, CMV, Herpes Simplex (TORCH) InfectionsOrder number Product name Legal Status Tests/SizeIntended use

BA413 Atypical CAP PCR testMultiplex Real-Time PCR test for detection of Atypical Community-Acquired Pneumonia (CAP) including Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila/ Legionella longbe-achae DNA

32

BA045 Avian Influenza A H5, H7, H9 RT-PCR Kit Real Time PCR test for detection of H5, H7, H9 subtypes of Influenza A virus RNA RUO 50

BA046 Avian Influenza A H5N1 RT-PCR Kit Real Time PCR test for detection or quantification of Avian A virus H5N1 subtype RNA 50, 60, 120

BA047 Bordetella PCR Kit Real Time PCR test for detection and/or typing of Bordetella pertus-sis/ B. parapertussis/ B. bronchiseptica / B. holmesii DNA 100

BA414 CAP bacteria PCR Kit Community Acquired Pneumonia – CAP 12, 60

BA415 hMPV RT-PCR Kit Real Time PCR test for detection of Human Metapneumovirus A and B RNA 48, 96

BA048 hRSV + hMPV multiplex RT-PCR KitReal Time PCR test for qualitative detection of human Respiratory Syncytial virus and human Metapneumovirus RNA from nasal ans nasapharyngial swab specimen

96

BA049 Human Respiratory Syncytial Virus (hRSV) RT-PCR Kit

Real Time PCR test for detection of hRSV RNA 32, 48, 50, 96

BA050 Influenza A H1N1 & H3N2 RT-PCR Kit Real Time PCR test for detection of H1N1 and H3N2 types of Influenza A RNA RUO 50

BA051 Influenza A/B RT-PCR KitMultiplex Real Time PCR test for detection and differentiation of influenza viruses (Influenza A, Influenza B and H1N1) from human nasal and throat; detecting the actual circulating avian influenza A (H5N8)

20, 32, 48, 50, 96, 100

BA052 Legionella pneumophila PCR Kit Real Time PCR test for quantitative detection of Legionella pneumo-phila DNA 50, 100

BA053 MERS-SARS CoV RT-PCR KitReal Time PCR test for detection and differentiation of Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome Coronaviruses RNA

48, 50, 96

BA054 Mycoplasma pneumoniae / Chlamydia. Pneumoniae PCR Kit

Real Time PCR test for detection of Chlamydia pneumoniae and/or Mycoplasma pneumonia DNA 48, 50, 96

BA416 Mycoplasma pneumoniae PCR Kit Real Time PCR test for identification of Mycoplasma pneumoniae genome by amplification of the P1 gene. 50

BA055 Parainfluenza (PIV) Virus RT-PCR Kit Real Time PCR test for detection of Parainfluenza virus RNA (Type 1, 2, 3 & 4) 32, 48, 50, 96, 100

BA056 Pseudomonas aeruginosa PCR Kit Real Time PCR test for quantitative detection of Pseudomonas aeruginosa DNA 50

Respiratory Infections

1.7 Respiratory Infections / TuberculosisOrder number Product name Legal Status Tests/SizeIntended use

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BA060 Mycobacterium tuberculosis PCR Kit Real Time PCR test for detection of Mycobacterium tuberculosis complex strains DNA 48, 50, 60, 96, 100,

BA418 TB Resistance Module 1Real Time PCR test and Amplification/ Reverse hybridization assay for the modular detection of Mycobacteria of the Mycobacterium tuberculosis complex and its resistances to Isoniazid and Rifampicin

12, 48, 60

BA419 TB Resistance Module 2Real Time PCR test and Amplification/ Real Time PCR test and Amplification/ Reverse hybridization assay for the modular detection of Mycobacteria of the Mycobacterium tuberculosis complex and its resistances to Fluoroquinolone antibiotics and Ethambutol

12, 48, 60

BA420 TB Resistance Module 3Real Time PCR test and Amplification/Reverse hybridization assay for the modular detection of Mycobacteria of the Mycobacterium tuberculosis complex and its resistances

12, 48, 60

BA421 TB Resistance Module 4Real Time PCR test for the modular detection of Mycobacteria of the Mycobacterium tuberculosis complex and its resistances to Streptomycin

48

Tuberculosis and TB Resistance

BA417 Respiratory Pathogens PCR Kit (21 pathogens)

Multiplex Real-Time PCR test for detection of 21 respiratory patho-gens for detection of influenza A, influenza A (H1N1) swl, influenza B, rhinovirus, coronavirus NL63, 229E, OC43, HKU1, parainfluenza 1, 2, 3, 4, human metapneumovirus A/B, bocavirus, respiratory syncytial virus A/B, adenovirus, enterovirus, parechovirus, mycoplasma

32

BA057 Respiratory Virus Panel multiplex RT-PCR Kit Real Time PCR test for detection of the genome of 16 main respira-tory viruses 20, 100

BA058 Swine Influenza Virus H1 RT-PCR Kit Real Time PCR test for detection of Swine Influenza Virus A/H1 RNA RUO 50

Respiratory Infections

1.7 Respiratory Infections / TuberculosisOrder number Product name Legal Status Tests/SizeIntended use

BA065 Listeria monocytogenes PCR Kit Real Time PCR test for detection and quantification of L. monocytogenes DNA RUO 50, 100

BA422 Neonatal Meningitis PCR Kit Multiplex Real Time PCR test for detection and quantification of Group B Streptococcus (S. agalactiae), Listeria monocytogenes, Escherichia coli DNA

32

BA423 Neuro PCR Kit (9 pathogensMultiplex Real-Time PCR test for detection of cytomegalovirus, Epstein-Barr virus, adenovirus, herpes simplex virus 1, 2, varicella-zoster virus, enterovirus, parechovirus, human herpes virus 6, 7, parvovirus B19

32

BA064 NHS Meningitidis PCR Kit Real Time PCR test for detection of N. meningitidis, H. influenzae, St. pneumonia DNA 50

BA424 Viral Meningitis PCR Kit Multiplex Real Time PCR test for detection of herpes simplex virus 1, 2, varicella-zoster virus, enterovirus, mumps virus, parechovirus 32

Meningititis

BA061 Enterovirus RT-PCR Kit Real Time PCR screening test for detection of Enterovirus (Coxsackie A, Coxsackie B, Echovirus, Enterovirus) RNA 32, 48, 50, 96

BA062 Enterovirus 71 RT-PCR Kit Real-Time PCR test for qualitative detection of Enterovirus-71 Virus (EV1) RNA 50

BA063 Poliovirus RT-PCR KitReal Time PCR test for qualitative detection of Poliovirus / Entero-virus group C(HEV-C) RNA and differentiation of Poliovirus strains Sabin 1, Sabin 2, Sabin 3 RNA

50

Enterovirus/Poliovirus

1.8 Neurological InfectionsOrder number Product name Legal Status Tests/SizeIntended use

12 bioactiva

BA067 A.I.I. (Acute Intestional Infections) PCR KitReal Time PCR test for detection of Shigella Spp., E.coli, Salmonella spp., Campylobacter spp., Adenovirus F, Rotavirus A, Norovirus 2, Astrovirus

50

BA605 Acinetobacter baumannii PCR Kit Real-time PCR test for detection of Acinetobacter baumannii DNA RUO 150

BA068 Adenovirus PCR Kit Real Time PCR test for detection and quantification of Adenovirus DNA species (A, B, C, D, E, and F) or serotypes (HAdV 1-52) 48, 50, 96

BA069 Aerobic complex PCR Kit Multiplex Real time PCR test for detection of Enterobacteriaceae (E. coli, Klebsiella spp, Proteus spp, Streptococcus spp) DNA RUO 50

BA070 Bacillus cereus PCR Kit Real Time PCR test for detection of Bacillus Cereus DNA 100

BA425 Bacterial Gastroenteritis PCR KitMultiplex Real-Time PCR test for detection and quantification of Bacterial gastroenteritis including Salmonella spp., Shigella spp., Yersinia enterocolitica, Clostridium difficile, Campylobacter coli/jejuni/lari, VTEC DNA

32

BA066 Bacterial Stool Panel PCR KitMultiplex Real Time PCR test for detection and differentiation of humanpathogenic Salmonella spp., Campylobacter spp. and Yersinia enterocolitica in human stool samples

100

BA071 Campylobacter PCR Kit Real Time PCR test for detection of Campylobacter jejuni DNA 25, 50, 100

BA072 Clostridium difficile PCR Kit Real Time PCR test for detection of Clostridium difficile Toxin A and B DNA 48, 50, 55, 96, 100

BA073 Clostridium perfringens PCR Kit Real Time PCR test for detection of Clostridium perfringens DNA 100

BA074 Cronobacter PCR Kit Real Time PCR test for detection of Cronobacter sakazakii DNA RUO 50, 100

BA075 E. coli O157 PCR Kit Real Time PCR test for detection of E. coli O157：H7 DNA 25, 150

BA076 EAEC PCR Kit Real Time PCR test for detection of Enteroadhesive E coli (EAEC) DNA 100

BA077 EHEC PCR Kit Real Time PCR test for detection of enterohemorrhagic E. coli (EHEC) DNA 48, 50, 96, 100

BA078 EIEC PCR Kit Real Time PCR test for detection of Enteroinvasive E. coli (EIEC) DNA 100

BA079 Enterobacter sakazaii PCR Kit Real Time PCR test for detection of Enterobacter sakazaii DNA 25

BA080 EPEC PCR Kit Real Time PCR test for detection of Enteropathogenic E. coli (EPEC)DNA 100

BA081 Escherichioses Screen & Differentiation Kit Real Time PCR test for detection of E.coli (EPEC, ETEC, EIEC, EHEC, and EAgEC) DNA RUO 50, 100

BA082 ETEC PCR Kit Real Time PCR test for detection of Enterotoxigenic E. coli (ETEC) DNA 100

BA426 Gut Balance PCR KitReal time PCR for the direct qualitative and quantitative detection of Bacteroides and Cluster XIVa DNA from human stool samples to judge symbiotic balance in gut microbiome

100

BA083 Helicobacter pylori PCR Kit Real Time PCR test for detection of H. pylori DNA e.g. by amplifica-tion of the UreC gene 32, 48, 50, 96

BA084 Hospital Stool Panel PCR KitReal Time PCR test for detection and differentiation of norovirus (genogroup I and II), rotavirus and Clostridium difficile toxin-genes A (tcdA) and B (tcdB) in human stool samples

100

BA087 Listeria PCR Kit Real Time PCR test for detection of Listeria monocytogenes DNA 32, 50, 96

BA088 Norovirus RT-PCR Kit Real Time PCR test for detection of Norovirus (Genogroup I, II and IV) RNA 32, 96

BA427 Rotavirus RT-PCR Kit Real Time PCR test for detection of Rotavirus RNA 48, 96

BA089 Rotavirus/Norovirus/ Astrovirus RT-PCR Kit Real Time PCR test for detection of Rotavirus, and/or Norovirus and/or Astrovirus RNA 50, 100

BA428 Salmonella spp. PCR Kit Real Time PCR test for identification of Salmonella spp genome by amplification of the Nuclease gene 50, 150

BA090 Sapovirus RT-PCR Kit Real Time PCR test for direct qualitative detection of Sapovirus (Sapporo virus genotypes I-V) RNA in stool 25, 100

BA429 Shigella spp. PCR Kit Real Time PCR test for identification of Shigella spp genome by amplification of the Yst gene 50

1.9 Gastrointestinal Infections / ParasitesOrder number Product name Legal Status Tests/SizeIntended use

bioactiva 13

BA429 Shigella spp. PCR Kit Real Time PCR test for identification of Shigella spp genome by amplification of the Yst gene 50

BA091 Shigella/Salmonella/ Campylobacter PCR Kit Real Time PCR test for detection of Shigella, and/or Salmonella and/or campylobacter DNA 25, 32, 50, 96

BA092 STEC PCR Kit Real Time PCR test for detection of Shigella Toxin-Producing E. coli (STEC) DNA 100

BA430 Verotoxin-producing Escherichia coli PCR Kit Real Time PCR test for detection of Verotoxin-producing E. coli VT1 DNA RUO 100

BA085 Viral Stool Panel PCR Kit Real Time PCR test for detection and differentiation of norovirus, rotavirus, adenovirus and astrovirus RNA in human stool samples 100

BA093 Yersinia PCR Kit Real Time PCR test for detection of Yersinia enterocolitica and/or Y. pseudotuberculosis DNA 32, 50, 96

1.9 Gastrointestinal Infections / ParasitesOrder number Product name Legal Status Tests/SizeIntended use

BA431 Cryptosporidium PCR KitReal Time PCR Kit for the in vitro quantification of Cryptosporidium (C. parvum, C. hominis [previously C. parvum genotype 1], C. canis, C. felis, C. meleagridis, and C. muris DNA

RUO 150

BA094 Dientamoeba PCR Kit Real Time PCR test for detection of Dientamoeba fragilis DNA 100

BA095 Entamoeba PCR Kit Real Time PCR test for detection of Entamoeba histolytica DNA 100

BA432 Giardia A+B PCR Kit Real Time PCR Kit for the in vitro quantification of Giardia intestinalis assemblages A and B DNA known to infect humans RUO 150

BA433 Giardia A-F PCR Kit Real Time PCR Kit for the in vitro quantification of Giardia intestinalis assemblages A to F DNA RUO 150

BA121 Leishmania (all species) PCR Kit Real Time PCR Kit for the in vitro quantification of Leishmania spp DNA via the cytochrome b (cytb) kinetoplast gene 48, 50, 150

BA434 Leishmania infantum & Leishmania donovani PCR Kit

Real Time PCR Kit for the in vitro quantification of Leishmania infantum & Leishmania donovani DNA RUO 50, 150

BA435 Leishmania major PCR Kit Real Time PCR Kit for the in vitro quantification of Leishmania major DNA RUO 50, 150

BA436 Leishmania tropica PCR Kit Real Time PCR Kit for the in vitro quantification of Leishmania tropica DNA RUO 50, 150

BA122 Malaria PCR Kit Real Time PCR test for screening/ detection of Malaria Parasite DNA 50, 96, 150

BA123 Malaria Screening PCR KitQualitative PCR strip test that allows to detect the presence of P. falciparum, P. malariae, P. ovale or P. vivax in DNA extracted from whole blood samples.

48

BA124 Malaria Typing PCR/ Agarose gel electrophoresis

Qualitative PCR strip test that allows to identify the presence of 3 of the 4 Plasmodia that infect humans (P. malariae, P. ovale or P. vivax) in DNA extracted from whole blood samples.

48

BA096 Parasitic Stool Panel PCR KitReal Time PCR test for detection of Dientamoeba fragilis, Giardia lamblia (synonym G. intestinalis or G. duodenales), Entamoeba histo-lytica and Cryptosporidium spp. parasites DNA in stool

100

Parasites / Protozoa

Parasites / Helminths

BA437 Ascaris lumbricoides/ Ascaris suum PCR Kit Real Time PCR Kit for identifying the appearance of the roundworms or eggs of Ascaris lumbricoides/ Ascaris suum preferably in feces RUO 3150

Parasites / Helminths

BA098 Chlamydophila pneumonia PCR Kit Real Time PCR test for detection or quantification of Chlamydophila pneumoniae DNA 32, 48, 96

BA099 John Cunningham Virus (JCV) PCR Kit Real Time PCR test for detection and quantification of JC Virus DNA 48, 50, 96

BA100 Polyomavirus BK (BKV) PCR Kit Real Time PCR test for detection or quantification of PBK virus DNA 25, 48, 50, 96

1.10 Further Infectious Diseases Order number Product name Legal Status Tests/SizeIntended use

BA437 Ascaris lumbricoides/ Ascaris suum PCR Kit Real Time PCR Kit for identifying the appearance of the roundworms or eggs of Ascaris lumbricoides/ Ascaris suum preferably in feces RUO 150

14 bioactiva

BA101 Babesia PCR Kit Real Time PCR test for detection of Babesia species (Babesia diver-gens, B. microti and B.sp EU1) 32, 96

BA102 Borrelia burgdorferi PCR Kit Real Time PCR test for detection of Borrelia burgdorferi DNA 32, 50, 96

BA103 Coxiella burnetii PCR Kit Real Time Amplification test for detection of Coxiella burnetii DNA RUO 50

BA104 Ehrlichia PCR KitReal Time PCR test for detection of the Ehrlichia species (E. chaffeenis, E. ewengii, Anaplasma phagocytophilum (formerly E. phagocytophilum, E. equi)

32, 96

BA105 Leptospira ssp. PCR Kit Real Time PCR test for detection of Leptospira DNA 50, 100

BA438 Tick-borne encephalitis (FSME) RT-PCR Kit Real Time PCR test for detection of Tick-borne encephalitis virus (TBEV) RNA 48, 50

BA106 Vibrio parahaemolyticus PCR Kit Real Time PCR test for detection of V. parahaemolyticus DNA 96

BA107 Vibrio Vulnificus PCR Kit Real Time PCR test for detection of V. vulnificus DANN 96

1.11 Tick Borne InfectionsOrder number Product name Legal Status Tests/SizeIntended use

BA109 Aspergillus fumigates PCR Kit Real Time PCR test for quantitative detection of Aspergillus fumiga-tes DNA in bronchoalveolar lavage, blood, plasma and serum 50

BA108 Aspergillus ssp. PCR Kit Real Time PCR test for detection of the most common species A. fumigatus, A. flavus, A. niger, and A. terreus DNA 4x 25

BA606 Candida ssp. PCR Kit Multiplex Real Time PCR test for detection of Candida albicans, C. glabrata and C. krusei DNA RUO 100

BA110 Cryptococcus neoformans PCR Kit Real Time PCR test for detection of Cryptococcus neoformans DNA inbronchoalveolar lavage, blood, plasma, serum, and cerebrospinal fluid 50, 100

BA439 Dermatophytes PCR Kit 1Multiplex PCR amplification/lateral flow detection kit for diagnosis of the pathogens T. rubrum, Dermatophyton spp. (TME), Scopulariopsis brevicaulis and Candida spp.

10, 50

BA440 Dermatophytes PCR Kit 2Multiplex PCR amplification/lateral flow detection kit for diagnosis of the pathogens T. interdigitale / A. vanbreuseghemii; T. mentag-rophytes, T. tonsurans, T. violaceum, A. benhamiae/ T. erinacei and T.verrucosu

10, 50

BA441 Dermatophytes PCR Kit 3Multiplex PCR amplification/lateral flow detection kit for diagnosis of the Microspores M. audouinii, M. gypseum, M. canis, as well as Epidermophyte E. floccosum on species level

10, 50

BA442 Dermatophytes, yeasts, mould or mixed infections PCR Kit

Multiplex Real Time PCR test for detection of Trichophyton mentag-rophytes complex, Trichophyton tonsurans, Trichophyton violaceum, Trichophyton rubrum complex, Microsporum canis, Microsporum audouinii, Microsporum ferrugineum DNA from skin scale specimens, plucked hair, nails, culture and swabs of human origin.

10, 32, 50, 64

1.12 Fungal and Yeast InfectionsOrder number Product name Legal Status Tests/SizeIntended use

BA603 Tropical fever core, 7 pathogens RT-PCR KitMultiplex Real-Time PCR Kit for detection of Burkholderia mallei, Burkholderia pseudomallei, Hantaan virus/Seoul virus, Leishmania spp. and Japanese Encephalitis virus

32, 64

BA604 Tropical fever Asia, 4 pathogens RT-PCR KitMultiplex Real-time PCR Kit for detection of dengue virus, c hikungunya virus, Salmonella spp., West Nile virus, Plasmodium spp., Rickettsia spp., Leptospira spp.

32, 64

BA111 Chikungunya Virus (Chik) RT-PCR Kit Real Time PCR test for detection of Chikungunya Virus RNA 96, 150

BA443 Chikungunya / Dengue PCR Kit Multiplex Real Time PCR kit for detection of Chikungunya and Dengue RNA 48, 96

BA112 Crimean–Congo hemorrhagic fever (CCHF) RT-PCR Kit

Real Time PCR test for detection of CCHF RNA 50, 60, 96, 120

BA444 Dengue Genotype RT-PCT Kit Real Time PCR kit for detection and differentiation of Dengue 1, 2, 3, 4 RNA 50

BA113 Dengue RT-PCR Kit Real Time PCR kit for detection and/or differentiation of Dengue 1, 2, 3, 4 RNA 50, 60, 96, 120

BA114 Ebola hemorrhagic fever Virus (Sudan, SE-BOV) RT-PCR Kit

Real Time PCR test for detection of SEBOV RNA from human samples RUO 60, 120

Viral diseases, hemorrhagic fevers

1.13 Emerging DiseasesOrder number Product name Legal Status Tests/SizeIntended use

bioactiva 15

1.13 Emerging DiseasesOrder number Product name Legal Status Tests/SizeIntended use

BA115 Ebola hemorrhagic fever Virus (Zaire, ZEBOV) RT-PCR Kit

Real Time PCR test for detection of ZEBOV RNA from human samples RUO 60, 96, 120

BA445 Filovirus Genotype RT-PCR Kit Real Time PCR kit for detection of Human pathogenic filoviruses and species differentiation 96

BA446 Filovirus Screen RT-PCR Kit Real Time PCR kit for detection of Human pathogenic filovirus species RNA 96

BA116 Lassa Virus (LV) RT-PCR Kit Real Time PCR test for detection of Lassa Virus (LV) RNA RUO 25

BA117 Marburg Virus (MARV) RT-PCR Kit Real Time PCR test for detection of MARV RNA from human samples RUO 120

BA118 Nipah Virus RT-PCR Kit Real Time PCR test for detection of Nipah Virus (NiV) RNA 25

BA447 Plasmodium spp. PCR Kit Real-time PCR test for detection of all Plasmodium species, 150 tests RUO 150

BA119 Rift Valley Fever (RVF) Virus RT-PCR Kit Real Time PCR test for detection of Rift Valley Fever (RVF) RNA RUO 60, 96, 120

BA120 West Nile Virus (WNV) RT-PCR Kit Real Time PCR test for detection of WNV RNA 25, 32, 50, 64, 96

BA448 BA448 Real Time PCR test for detection of Zika Virus RNA 24, 48, 96, 150

BA122 Malaria PCR Kit Real Time PCR test for screening/ detection of Malaria Parasite DNA 96, 150

BA123 Malaria Screening PCR/Agarose gel electrophoresis

Qualitative PCR strip test that allows to detect the presence of P. falciparum, P. malariae, P. ovale or P. vivax in DNA extracted from whole blood samples.

48

BA124 Malaria Typing PCR/ Agarose gel electrophoresis

Qualitative PCR strip test that allows to identify the presence of 3 of the 4 Plasmodia that infect humans (P. malariae, P. ovale or P. vivax) in DNA extracted from whole blood samples.

48

Parasites

BA449 Bartonella henselae PCR Kit Real Time PCR test for the identification of the Bartonella henselae genome by amplification of the ribC gene 50

BA450 Neonatal Sepsis PCR Kit (7 Pathogens)Multiplex Real Time PCR test for detection and quantification of cytomegalovirus, Group B Streptococcus (S. agalactiae), Listeria monocytogenes, Escherichia coli, Staphylococcus aureus, Chlamydia trachomatis, Ureaplasma urealyticum/ parvum DNA

32

BA125 Pseudomonas aeruginosa PCR Kit Real Time PCR test for quantitative detection of Pseudomonas aeruginosa DNA 50

BA451 Rickettsia spp. PCR Kit Real Time PCR test for the identification of Rickettsia spp. genome by amplification of gltA gene 50

BA126 Streptococcus B PCR Kit Real Time PCR test for quantitative detection of Streptococcus B DNA 100

BA127 Streptococcus group A and pyogenic group C and G PCR Kit

Real Time PCR test for the qualitative detection and differentiation of group A streptococcal and pyogenic group C and G streptococcal nucleic acids isolated from throat swab specimens obtained from pa-tients with signs and symptoms of pharyngitis, such as a sore throat.

96

BA128 Streptococcus pyogenes PCR Kit Real Time PCR test for quantitative detection of Streptococcus pyogenes DNA RUO 100

1.14 Bacteriology / Sepsis / Pyogenic InfectionsOrder number Product name Legal Status Tests/SizeIntended use

BA129 Carbapenems resistance PCR KitReal Time PCR test for detection of Enterobacteriaceae and Pseudo-monas resistance against carbapenems, genes VIM, NDM, OXA-48, KPC

RUO 60

BA130 Cephalosporins resistance PCR KitReal Time PCR test for detection of Enterobacteriaceae resistance against cephalosporins, genes CTX-M, or S. aureus resistance against cephalosporins, genes MecA

RUO 60

BA131 Glycopeptides resistance PCR KitReal Time PCR test for detection of Enterococcus faecalis and E. faecium resistance to Vancomycin and Teicoplanin, genes VanA and VanB

RUO 60

1.15 Bacterial Drug ResistanceOrder number Product name Legal Status Tests/SizeIntended use

Viral diseases, hemorrhagic fevers

16 bioactiva

BA452 H. pylori clarithromycin resistance PCR KitReal Time PCR test for detecting Helicobacter pylori A2142C, A2142G and A2143G point mutations in H. pylori genomic DNA, conferring clarithromycin resistance to the bacterium

50

BA132 Macrolides resistance PCR KitReal Time PCR test for detection of Streptococcus spp. and Staphy-lococcus spp resistance to macrolides, lincosamides, streptogramins; genes ErmB and Mef

RUO 60

BA133 MDR KPC / OXA PCR Kit Real Time PCR kit for detection of the genes KPC, OXA-48 and OXA-162 in Enterobacteriaceae and NFGNB 100

BA134 MDR MBL (VIM, IMP, NDM) PCR Kit Real Time PCR test for detection of the genes VIM, IMP and NDM in Enterobacteriaceae and NFGNB 100

BA135 MRSA PCR Kit Real Time PCR test for detection or quantification of Methicillin-resistant Staphylococcus aureus (MRSA) DNA 25, 32, 50, 96, 100

BA136 Penicillins resistance PCR KitReal Time PCR test for detection of Enterobacteriaceae and Pseudo-monas resistance to penicillins and first-generation cephalosporins, genes TEM

RUO 60

BA137 PVL PCR KitReal Time PCR test for detection of PVL (Panton-Valentine-Leukozidin)-positive S. aureus DNA as an aid in diagnosis of (skin- / soft tissue-) infections caused by PVL

100

BA453 Q-MRSA Detection PCR Kit Multiplex Real Time PCR test for simultaneous detection of the 3 MRSA markers nuc, mecA and orfX‐SCCmec RUO 10, 20

BA138 VRSA PCR Kit Real Time PCR test for detection of Vancomycin-resistant Staphylococcus aureus VRSA DNA 25

1.15 Bacterial Drug ResistanceOrder number Product name Legal Status Tests/SizeIntended use

BA139 Periodontitis Screening PCR KitReal Time PCR test for detection of Porphyromonas endodontalis, Porphyromonas gingivalis, Aggregatibacter ctinomycetemcomitans, Treponema denticola, Fusobacterium nucleatum, Prevotella interme-dia, Tannerella forsythia in periodontal samples

RUO 50

1.16 PeriodontitisOrder number Product name Legal Status Tests/SizeIntended use

BA140 Anthrax PCR Kit Real Time PCR test for detection of Bacillus anthracis DNA 50, 96

BA141 Botulinus PCR Kit Real Time PCR test for detection of Botulinus (Types A/B/E/F) DNA 25

BA142 Brucella PCR Kit Real Time PCR test for detection of Brucella DNA i.e. by amplification of the bcsp31 gene 50, 100

BA143 Set of PCR Kits for detection and quantifica-tion of Biothreat high risk pathogen DANN

Real Time PCR kits to detect Bacillus anthracis, Burkholderia spp. (B. mallei, B. pseudomallei), Brucella spp. (B. melitensis, B. suis, B. abortus, B. ovis, B. canis), Francisella tularensis, Salmonella enterica, Yersinia pestis.

RUO 50

BA144 Vibrio cholerae PCR Kit Real Time PCR test for detection of Vibrio cholerae strains iCtxA, tcpA and/or O139 DNA 25, 50, 96

BA145 Yersinia pestis PCR Kit Real Time Amplification test for detection of Yersinia pestis DNA RUO 50

1.17 Biothreat AgentsOrder number Product name Legal Status Tests/SizeIntended use

2. ONCOLOGY

BA454 BCR-ABL P210/P190 PCR KitMultiplex Reverse Transcription Real-time PCR test for in vitro quantification of both the BCR-ABL fusion transcripts P210/P190 in one tube

24

BA146 M-BCR/t(9;22) PCR KitReal-time PCR test for in vitro quantification of BCR-ABL fusion transcripts comprising the (Ph+) translocation t(9;22) major break-point cluster regions (M-BCR) b2a2 and b3a2) in CML

25, 48, 50, 96, 120

BA147 mi-BCR/t(9;22) PCR KitReal-time PCR test for in vitro quantification of BCR-ABL fusion transcripts comprising the (Ph+) translocation t(9;22) minor break-point cluster region (M-BCR) e1a2 in CML

48, 96, 120

Chronic Myelogenous Leukaemia

2.1 Oncogene Expression Quantification / Minimal Residual Disease (MRD) Order number Product name Legal Status Tests/SizeIntended use

bioactiva 17

BA455 ALL Fusion Screening PCR KitMultiplex Reverse Transcription Real-time PCR test for simultaneous detection and quantification of 16 fusion genes with 71 breakpoints in leukemia patients with ALL

10, 20

BA456 AML Fusion Screening PCR KitMultiplex Reverse Transcription Real-time PCR test for simultaneous detection and quantification of 16 fusion genes with 72 breakpoints in leukemia patients with AML

10, 20

BA148 AML1-ETO/t(8;21) PCR Kit Real-time PCR test for identification and quantitation of the t(8;21)(q22;q22) translocation with AML1-ETO fusion transcripts 25, 48, 96

BA149 CBFB-MYH11 A/inv(16) PCR Kit Real-time PCR test for the identification and quantitation of inv(16)(p13;q22) inversion with CBFB-MYH11 A fusion transcripts 25, 48, 96

BA150 PML-RARa/t(15;17) PCR KitReal-time PCR test for in vitro quantification of PML-RARa/t(15;17) fusion transcripts covering all three known regions of the PML locus in AML M3

48, 96, 120

BA151 TEL-AML1/t(12;21) PCR Kit Real-time PCR test for in vitro quantification of TEL-AML1 fusion transcripts t(12;21) in AML1 RUO 120

BA601 TCF3-PBX1/ t(1;19) PCR Kit Multiplex Real-time PCR test for chromosome translocation t(1;19) (q23;p13)(TCF3-PBX1) screening associated with leukemia 25

BA607 MLL-AFF1 t(4;11) PCR Kit Multiplex RT-PCR screening test for chromosome translocation t(4;11)(q21;q23)(MLL-AFF1) associated with leukemia 25

Acute Myelogenous / Acute Lymphatic Leukaemia

BA152 BCL-2/t(14;18) PCR KitKit for the detection of the BCL-2 gene t(14;18) (q32;q21) transloca-tion. Target regions (nested PCR): Major Break-point Region (MBR), minor cluster region (mcr)

25, 50

BA153 Cyclin D1/BCL-1/t (11;14) PCR KitReal-time PCR test for the detection of the bcl-1 gene t(11,14) (q13;q32) translocation. Target regions: Major Translocation Cluster (MTC) region

25, 50

Lymphoma

BA154 Screening Kit for leukemia associated trans-locations (7 translocations)

Multiplex Real-time PCR test for the detection and/or quantification of 7 translocations found in AML, ALL and CML including:· TCF3-PBX1; t(1;19)(q23;p13)· MLL-AFF1; t(4;11)(q21;q23)· RUNX1-RUNX1T1; t(8;21)(q22;q22)· BCR-ABL1 (M-BCR; P190, P210, P230); t(9;22)(q34;q11)· ETV6-RUNX1; t(12;21)(p13;q22)· PML-RARA (bcr1, bcr2, bcr3); t(15;17)(q24;q21)· CBFB-MYH11; inv(16)(p13;q22)

12

BA457 Screening Kit for leukemia associated translocations (9 translocations)

Multiplex Real-time PCR test for the detection and/or quantification of 7 translocations found in AML, ALL and CML including:· MLL-AF9; t(9;11)(p22;q23)· PML-RARa; t(15;17)(q24;q21)· AML1-ETO; t(8;21)( q22; q22)· MLL-AF4; t(4;11)(q21;q23)· TEL-AML1; t(12;21)(p13;q22)· E2A-PBX1; t(1;19)(q23;p13)· MLL-ENL; t(11;19)(q23;p13.3)· BCR-ABL1; t(9;22)(q34;q11)· SIL-TAL1; del(1)(p32)

10, 20

BA458 Screening Kit for leukemia associated translocations (28 translocations)

Multiplex Real-time PCR test for the detection and/or quantification of 28 translocations found in AML, ALL and CML including:· CBFB-MYH11; inv(16)(p13;q22)· RUNX1-RUNX1T1; t(8;21)(q22;q22)· PML-RARA (bcr1, bcr2, bcr3); t(15;17)(q24;q21)· MLL-MLLT3; t(9;11)(p22;q23)· MLL; t(11;19)(q23;p13.3); ELL, MLLT1· FUS-ERG; t(16;21)(p11;q22)· ETV6-MN1; t(12;22)(p13;q11-12)· DEK-NUP214; t(6;9)(p23;q34)· MLL-EPS15; t(1;11)(p32;q23)· MLL-MLLT4; t(6;11)(q27;q23)· TCF3-PBX1; t(1;19)(q23;p13)· ETV6-RUNX1; t(12;21)(p13;q22)· MLL-AFF1; t(4;11)(q21;q23)· TCF3-HL; t(17;19)(q22;p13)· STIL-TAL1; del(1)(p32)· BCR-ABL1 (M-BCR; P190, P210, P230); t(9;22)(q34;q11)· ET-NUP214; t(9;9)(q34;q34)· ZBTB16-RARA, MLL-MLLT6; t(11;17)(q23;q21)· ETV6-ABL1; t(9;12)(q34;p13)· ETV6-PDGFRB; t(5;12)(q33;p13)· MLL-MLLT10; t(10;11)(p12;q23)· MLL-MLLT11; t(1;11)(q21;q23)· MLL-FOXO4; t(X;11)(q13;q23)· RUNX1-MECOM; t(3;21)(q26;q22)· NPM1-RARA; t(5;17)(q35;q21)· NPM1-MLF1; t(3;5)(q25.1;q35)· Reference genes c-ABL, GUS, B2M

12

CML / AML / ALL Translocation Screening


18 bioactiva


BA459 Leukemia Fusion Genes Screening PCR Kit (30 translocations)

Multiplex Reverse Transcription Real-time PCR test for simultaneous detection of 30 fusion genes in leukemia patients including:· MLL-AF9; t(9;11)(p22;q23)· PML-RARα; t(15;17)(q24;q21)· AML1-ETO; t(8;21)( q22; q22)· MLL-AF4; t(4;11)(q21;q23)· TEL-AML1; t(12;21)(p13;q22)· E2A-PBX1; t(1;19)(q23;p13)· MLL-ENL; t(11;19)(q23;p13.3)· BCR-ABL1; t(9;22)(q34;q11)· SIL-TAL1; del(1)(p32)· MLL-AF10; t(10;11)(p12;q23)· CBFβ-MYH11; inv(16)(p13;q22)· AML1-MDS1/EV11; t(3;21)(q26; q22)· FIP1L1-PDGFRA; del(4)(q12)· SET-CAN; del(9)(q34)· E2A-HLF; t(17;19)(q22;p13)· DEK-CAN; t(6;9)(p23;q34)· MLL-SEPT6; t(X;11)(q24;q23)· TLS-ERG; t(16;21)(p11;q22)· TEL-PDGFRB; t(5;12)(q33;p13)· MLL-ELL; t(11;19)(q23;p13.1)· MLL-AF17; t(11;17)(q23; q21)· NPM-RARa; t(5;17)(q35;q21)· NPM-MLF1; t(3;5)(q25;q34)· PLZF-RARa; t(11;17)(q23;q21)· MLL-AF1q; t(1;11)(q21;q23)· MLL-AF1P; t(1;11)(p32;q23)· TEL-ABL1; t(9;12) (q34;p13)· AML1-MTG16; t(16;21)(q24;q22)· AML1-EAP; t(3;21)( q26; q22)· MLL-AF6; t(6;11)(q27;q23)

10, 20

CML / AML / ALL Translocation Screening

BA460 STR-VNTR PCR KitKit for detection of chimerism after allogenic bone marrow trans-plantation by analysis of Short Tandem Repeats (STR) and Variable Number of Tandem Repeats (VNTR). Target regions: HumARA, HumTH01, SE33, vWF2, D1S80, YNZ22, vWF1 and 3’-HVR

25, 50

Chimerism Detection in Leukemia

BA156 WT1 PCR Kit Real-time PCR test for identification and quantitation of the Wilm’s tumor gene transcripts 48, 96

Nephroblastoma

BA157 BRCA Panel PCR Kit Real-time PCR Kit for in vitro detection of BRCA 1 + 2 RUO 100

BA158 HER2/NEU PCR Kit Real-time PCR test for in vitro quantification of HER2/NEU transcripts RUO 120

Breast and Ovarian Cancer

BA461 HPV E6/E7 mRNA RT-PCR Kit Real-time RT-PCR Kit for differentiation between persistent and transient high-risk HPV infection for all women over the age of 30, for cervical and oral testing

92

Cervical and Head-Neck Cancer

BA159 AFP PCR Kit Real-time PCR test for in vitro quantification of a Fetoprotein (AFP) mRNA in peripheral blood and bone marrow 25

Hepatocellular Cancer

BA160 Tyrosinase PCR KitReal-time PCR test for in vitro quantification of tyrosinase transcripts in peripheral blood and bone marrow (marker of recurrence and survival)

RUO 120

Malignant Melanoma

BA161 Survivin PCR KitReal-time PCR test for in vitro quantification of total survivin transcripts, including all known splice variants (unfavourable prognostic factor of de novo AML, soft tissue sarcoma and bladder cancer)

RUO 120

Soft Tissue Sarcoma and Bladder Cancer

BA462 EML4-ALK Fusion Gene Detection Kit PCR KitMultiplex Reverse Transcription Real-time PCR test for simultaneous detection of 17 fusion variants for the detection of EML4-ALK asso-ciated fusion gene transcripts (EML4-ALK V1, V2, V3a/b/c, V4, V5a/b, V6a/b, V7, V8a/b/c/d, V9, V10) in total RNA from lung cancer tissues

10, 20

BA463 Lung Cancer ALK / ROS1 / RET Panel PCR KitMultiplex Reverse Transcription Real-time PCR test for simultane-ous detection of 6 lung cancer fusion genes (KIF5B-RET, KIF5B-alk, CD74-ROS1, TGF-alk, SLRC34A2-ROS1, EML4-alk; 35 variants) in total RNA from lung cancer tissues

10, 20

Lung Cancer

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2.2 Somatic Mutations with Therapeutic Implications in Various CancersOrder number Product name Legal Status Tests/SizeIntended use

BA165 ABL Mutation Detection PCR KitReal-time PCR test for in vitro detection of the T315I (944C>T) so-matic mutation in the ABL oncogene in CML patients with secondary resistance to Imanitib (Gleevec)

RUO 24, 50

BA166 BRAF Mutation PCR Kit I Real time PCR test for the identification of the V600E mutation in the BRAF gene by sequence specific primer (SSP) PCR

12, 24, 36, 48, 60, 96

BA465 BRAF Mutation PCR Kit II Real time PCR test for the identification of the BRAF Codon Specific Mutations in Codon 600 10, 30, 60

BA171 CALR Mutation PCR Kit PCR test for detection of type 1 and type 2 mutations in exon 9 of the calreticulin (CALR) gene (agarose gel detection!!) 50

BA167 CC-MSI PCR KitTest for the analysis of microsatellite instability in colon-rectal cancer by multiplex amplification with fluorescent primers and subsequent fragment analysis by automatic DNA sequencing

24, 48

BA466 c-KIT Mutation PCR KitReal-time qualitative PCR assay for the detection of somatic mutations in Codon 861 of Exon 17 in the c-KIT proto-oncogene in genomic DNA from human cells or tissues

RUO 10, 30, 60

BA168 EGFR Mutation PCR Kit I Real time PCR test for the identification of the EGFR gene L858R & del 746-750 mutations 12, 24, 36

BA467 EGFR Mutation PCR Kit II Real time PCR test for the identification of the EGFR Codon Specific Mutation in Codons 719, Ex19Del, 790, 858 & 861 10, 30, 60

BA468 HRAS Mutation PCR Kit Real-time qualitative PCR test for the detection of mutations in codon 61 of the human HRAS gene RUO 10, 30, 60

BA172 JAK-2 Mutation PCR KitReal time PCR test for the identification and/or absolute quantifica-tion of codon 617 specific mutations in the Janus Kinase 2 (JAK-2) gene

10, 30, 48, 60, 96

BA169 KRAS Mutation PCR Kit IReal time PCR test for the identification of the seven most frequent mutations in the KRAS gene (G12D, G12V, G12A, G12C, G12S, G12R, G13D) by sequence specific primer (SSP) PCR

12, 24, 36, 48, 60, 96

BA469 KRAS Mutation PCR Kit II Real time PCR test for the identification of the KRAS Codon Specific Mutations in Codons 12, 13, 59, 61, 117 & 146 10, 30, 60

BA170 NRAS Mutation PCR Kit Real time PCR test for the identification of the NRAS gene 35G>T (G12V) mutation in codon 12 12, 24, 60

BA470 PIK3CA Mutation PCR KitReal-time qualitative PCR test for the detection of somatic muta-tions in and near PIK3CA Codons 542 and 545 in Exon 9 and Codon 1047 in Exon 20 in the human PIK3CA gene

10, 30, 60

BA164 18S rRNA PCR Kit Real-time PCR Kit for in vitro quantification of 18S rRNA transcripts RUO 120

BA162 c-ABL PCR Kit Real-time PCR Kit for in vitro quantification of c-ABL transcripts RUO 120

BA163 GAPDH PCR Kit Real-time PCR Kit for in vitro quantification of GAPDH transcripts RUO 120

BA464 p53 PCR Kit Real-time PCR test for in vitro quantification of p53 cDNA RUO 120

Reference Gene Transcripts/ “Housekeeping Genes”

3. HUMAN GENETIC DISEASES AND GENETIC PREDISPOSITIONS

BA182 ACE (I/D) PCR KitReal Time PCR test for the identification and genotyping of the insertion/deletion (I/D) polymorphism located on intron 16 of the human gene coding for angiotensin converter enzyme (ACE)

48, 50, 96

BA174 Cardio Thrombophilia Panel PCR KitReal Time PCR test for detection of 8 mutations: F2 20210 G>A, F5 1691 G>A (Arg506Gln), F710976 G>A (Arg353Gln), F13 G>T (Val34Leu), FGB -455 G>A, ITGA2 807 C>T (Phe224Phe), ITGB3 1565 T>C(Leu33Pro), SERPINE1(PAI1) -675 5G>4G

RUO 48

BA602 Factor II PCR KitReal-time PCR test for the identification and genotyping of the G20210A mutation in the human gene coding for Coagulation Factor II

48, 50, 60, 96

BA176 Factor V Leiden PCR KitReal-time PCR test for identification and genotyping of either the G1691A (Leiden) or Y1702C mutation in the human gene coding for Coagulation Factor V

12, 48, 50, 60, 96, 100

3.1 ThrombophiliaOrder number Product name Legal Status Tests/SizeIntended use

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BA177 Factor VII PCR KitReal-time PCR test for identification and genotyping of the G1238A (R353Q) mutation in the human gene coding for Coagulation Factor VII

RUO 50, 60, 96

BA178 Factor VIII PCR KitReal-time PCR test for the identification and genotyping of the G100T (Val34Leu) polymorphism in Factor VIII gene from blood samples

25, 50, 100

BA179 Factor XII PCR Kit Real-time PCR test for the identification and genotyping of the C4T (rs1801020) polymorphism in Factor XII gene from blood samples RUO 60, 96

BA180 Factor XIII PCR KitReal-time PCR test for the identification and genotyping of the G103T (Val35Leu; rs5985)) polymorphism in Factor XIII A1 gene from blood samples

RUO 60, 96

BA183 FGB PCR Kit Real Time PCR test for detection of fibrinogen beta gene polymor-phism G455A (rs1800790) RUO 60, 96

BA181 Folates Metabolism Panel PCR KitReal Time PCR test for detection of 4 polymorphism: MTHFR 677 C>T (Ala222Val), MTHFR 1298A>C (Glu429Ala), MTR 2756 A>G (Asp3919Gly), MTRR 66 A>G (Ile22Met)

RUO 12, 48, 60

BA184 GPIBA1b PCR KitReal Time PCR test for detection of platelet glycoprotein Iba gene polymorphisms C482T (Thr145 Met; rs6065) or T5C (Kozak sequence polymorphism; rs2243093)

RUO 60, 96

BA185 ITGA2 PCR Kit Real Time PCR test for detection of Integrin alpha2 gene polymor-phism T176C (rs1126643) RUO 60, 96

BA186 ITGB3 PCR Kit Real Time PCR test for detection of Integrin alpha2 gene polymor-phism T176C (Leu33Pro; rs5918) RUO 60, 96

BA187 MTHFR PCR KitReal Time PCR test for the identification and genotyping of either the C677T or A1298C polymorphism in the human gene coding for MTHFR

25, 48, 50, 96, 100

BA188 MTR PCR Kit Real Time PCR test for detection of methionine synthase gene muta-tion A2756G (Asp919Gly; rs1805087) RUO 60, 96

BA189 MTRR PCR Kit Real Time PCR test for detection of A66G methionine synthase gene polymorphism (Ile22Met; rs1801394) RUO 60, 96

BA190 PAI-1/Serpin PCR KitReal Time PCR test for the identification and genotyping of the 675 4G/5G insertion/deletion polymorphism in the human gene coding for SERPINE1 or plasminogen activator type 1 inhibitor gene (rs1799768)

25, 48, 50, 96

BA191 SELPLG PCR Kit Real Time PCR test for detection of selectin P ligand gene polymor-phism G186A (Met62Ile; rs2228315) RUO 60, 96

BA192 β-Fibrinogen (G455A) PCR Kit Real Time PCR test for the allelic discrimination of polymorphisms G455A in β-Fibrinogen gene from blood 50

3.1 ThrombophiliaOrder number Product name Legal Status Tests/SizeIntended use

BA193 AGT 1 PCR Kit Real Time PCR test for detection of Angiotensinogen 1 polymorphism C521T (Thr207Met, rs4762) RUO 60, 96

BA194 AGT 2 PCR Kit Real Time PCR test for detection of Angiotensinogen 2 polymorphism C4072T (Met235Thr, rs699) RUO 60, 96

BA195 AGTR1 PCR Kit Real Time PCR test for detection of angiotensin II receptor, type 1 polymorphism A1166C (rs5186) RUO 60, 96

BA196 Cardio Hypertension Panel PCR KitReal Time PCR test for detection of 8 mutations: ADD1 1378 G>T (Gly460Trp), AGT 704 T>C (Met235Thr), AGT 521 C>T (Thr174Met), AGTR1 1166 A>C, AGTR2 1675 G>A, CYP11B2 -344 C>T, GNB3 825 C>T, NOS3 -786 T>C, NOS3 894 G>C (Glu298Asp)

RUO 48

BA471 CVD Panel PCR KitAmplification/Reverse hybridization assay for detection of mutation FV:Q506 in factor V gen, of polymorphism 20210A in factor II gen, the MTHFR risk alleles for coronary disease, and the risk markers of PAI-1 gen in cardiovasculare disease (CVD)

RUO 12, 60

BA472 Coagulation panel PCR Kit Real Time PCR test for detection of coagulation factors FII G20 210A, FV G1691A and Y1702C and MTHFR C677T and A1298C mutations 50

BA198 NOS3 PCR Kit Real Time PCR test for detection of Nitric oxide synthase 3 polymor-phism C786T (rs2070744) RUO 60, 96

3.2 Cardiovascular Disease Order number Product name Legal Status Tests/SizeIntended use

Hypertension

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BA217 Anticoagulants Genetic Resistance PCR Kit Real Time PCR test for detection of Anticoagulants Genetic Resistance 25

3.2 Cardiovascular Disease Order number Product name Legal Status Tests/SizeIntended use

BA218 CYP2C9*3 PCR Kit Real Time PCR test for detection of CYP2C9 gene polymorphism A1075C (Ile359Leu; rs1057910) RUO 60, 96

BA219 Pharmacogenetics Warfarin Panel PCR Kit Real Time PCR test for detection of 3 mutations: CYP2C9 430 C>T (Arg144Cys), CYP4F2 C>T, (Val433Met), VKORC1 -1639 G>A RUO 20, 48

BA220 VKORC1 PCR KitReal Time PCR test for detection of Vitamin K epoxide reductase complex subunit 1 gene polymorphism С1173T (Warfarin sensitivity rs9934438) or G3730A (Warfarin sensitivity rs7294)

RUO 60, 96

Warfarin Resistance

BA199 AGT1 PCR Kit Real Time PCR test for detection of Angiotensinogen 1 polymorphism C521T (Thr207Met, rs4762) RUO 60, 96

BA200 ApoB PCR Kit Real Time PCR test for the allelic discrimination of polymorphisms R3500Q in Apo B gene from blood 50

BA201 ApoE PCR Kit 1 Real Time PCR test for detection of apolipoprotein E polymorphism T3100C (Leu48Pro, rs769452) RUO 60, 96

BA202 ApoE PCR Kit 2Real Time PCR test for the allelic discrimination of polymorphisms T334C (C112R) and C472T (R158C) in apolipoprotein E gene from blood

50

BA203 GP IIb/IIIa PCR KitReal Time PCR test for the allelic discrimination of polymorphism T1565C in GPIIIa gene (ITGB3, most abundant receptor on platelet surface) from blood

50

BA204 GP1BA1b PCR Kit Real Time PCR test for detection of the Platelet glycoprotein Iba polymorphism C482T (Thr161Met, rs6065) or T5C (rs2243093) RUO 60, 96

BA205 ITGA2 PCR Kit Real Time PCR test for detection of integrin alpha 2 polymorphism ：807T (Phe253Phe, rs1126643) RUO 60, 96

BA206 ApoB PCR Kit Real Time PCR test for the allelic discrimination of polymorphisms R3500Q in Apo B gene from blood 50

BA207 ApoE PCR Kit 1 Real Time PCR test for detection of apolipoprotein E polymorphism T3100C (Leu48Pro, rs769452) RUO 60, 96

BA208 ApoE PCR Kit 2Real Time PCR test for the allelic discrimination of polymorphisms T334C (C112R) and C472T (R158C) in apolipoprotein E gene from blood

50

BA209 LIPC PCR Kit Real Time PCR test for detection of paraoxonase 1 polymorphism G250A (rs2070895) RUO 60, 96

BA210 LPL PCR Kit Real Time PCR test for detection of lipoprotein lipase polymorphism C1421G (Ser447Thr, rs328) RUO 60, 96

BA211 PON1 PCR Kit Real Time PCR test for detection of paraoxonase 1 polymorphism A575G (Gln192Arg, rs662) RUO 60, 96

Myocardial Infarction & Ischemic Stroke

Lipid Metabolism

BA212 ADRB2 PCR KitReal Time PCR test for detection of adrenoceptor beta 2, surface gene poly-morphism G46A (Arg16Gly, rs1042713) or C5318G (Gln27Glu, rs1042714)

RUO 60, 96

BA213 ADRB3 PCR Kit Real Time PCR test for detection of β-adrenergic receptor gene polymorphism T190C (Trp64Arg, rs4994) RUO 60, 96

BA214 FABP2 PCR Kit Real Time PCR test for detection of of Fatty Acid Binding Protein 2 gene polymorphism A163G (Ala54Thr, rs1799883) RUO 60, 96

BA215 FTO PCR Kit Real Time PCR test for detection of FTO gene polymorphism A23525T (rs9939609) RUO 60, 96

BA216 PPARG2 PCR Kit Real Time PCR test for detection of Peroxisome Proliferator-Activated Receptor-Gamma-2 polymorphism C34G (Pro12Ala, rs1801282) RUO 60, 96

3.3 Diabetes and Obesity Order number Product name Legal Status Tests/SizeIntended use

3.4 Pharmacogenetics Order number Product name Legal Status Tests/SizeIntended use

Anticoagulants

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3.4 Pharmacogenetics Order number Product name Legal Status Tests/SizeIntended use

3.5 Genetic Diseases Order number Product name Legal Status Tests/SizeIntended use

BA228 Alpha-Globin PCR KitAmplification/reverse-hybridization assay for detection of 21 muta-tions covering >90% of a-globin defects found in Mediterranean, Middle Eastern and Southeast Asian countries

10

BA229B Beta-Globin Plus PCR TestAmplification/reverse-hybridization assay for the identification of 14 polymorphisms of beta-globin gene and alpha-globin anti 3.7 gene triplication variant

20

BA481 Familial Mediterranean fever (FMF) PCR KitAmplification/reverse-hybridization assay for detection of 12 muta-tions in the MEFV gene: E148Q, P369S, F479L, M680I (G >C, G >A), I692 del, M694V, M694I, K695R, V726A, A744S, R761H

20

BA230 β-Globin IME PCR KitAmplification/reverse-hybridization assay for detection of 22 mutations covering >90% of β-globin defects found in the Middle East and India

20

BA229A β-Globin MED PCR KitAmplification/reverse-hybridization assay for detection of 22 mu-tations covering >90% of β-globin defects found in Mediterranean countries

20

BA231 β-Globin SEA PCR Kit Amplification/reverse-hybridization assay for detection of 22 muta-tions covering >90% of β-globin defects found in Southeast Asia 20

Thalassemia / FMF

BA225 DDK/G17 PCR KitPCR Test for the detection of deletions in the Duchenne and Becker muscular dystrophy gene. Target regions: exons 3, 4, 6, 8, 13, 17, 19, 43, 44, 45, 47, 48, 49, 50, 51, 52, 60

25, 50

Muscular Dystrophy

BA478 Huntington disease PCR KitPCR amplification/fluorescent determination of the number of CAG repetitions in IT15 gene, detection of normal, premutated and muta-ted alleles by capillary electrophoresis in genetic analyzer

16

Chorea Huntington

BA226 Cystic fibrosis PCR Kit Deletion & insertion mutation PCR test, reverse dot blot on strip 25

Cystic Fibrosis

BA479 Haemochromatosis Panel PCR KitReal Time PCR test for detection of up to 3 or the single mutations HFE 187 C>G (H63D) and/or HFE 193 A>T (S65C) and/or HFE 845 G>A (C282Y) in the human HFE gene

12, 24, 25, 48, 50, 60, 96

Haemochromatosis

BA480 Osteoporosis Panel PCR KitAmplification/reverse-hybridization assay for simultaneous detection of the most important osteoporosis risk alleles for vitamin D receptor B/b and collagen I alpha 1 S/s allel

12, 60

Osteoporosis

BA221 CYP2C19*2 PCR Kit Real Time PCR test for detection of cytochrome P450 CYP2C19 gene polymorphism G681A (rs4244285) (Poor Metabolizer Allel) RUO 12, 60, 96

BA222 CYP2C19*3 PCR Kit Real Time PCR test for detection of CYP2C19 gene polymorphism G636A) (rs4986893) RUO 60, 96

Clopidogrel (Plavix) Resistance

BA476 Fragile X Screening PCR KitPCR amplification/fluorescent fragment analysis of the FMR1 CGG triplet repeat region (healthy and premutated alleles: 10 to 200 CGG triplet repeats) by capillary electrophoresis in genetic analyzer

16, 48

BA477 Fragile X Confirmatory PCR KitPCR amplification/fluorescent detection of mutated alleles of the FMR1 gene for confirmation of normal homozygous female samples and determination of the AGG interrumptions by capillary electro-phoresis in genetic analyzer

16

Fragile X Syndrome

BA223 CYP3A5*3 PCR Kit Real Time PCR test for detection of CYP3A5 gene polymorphism G6986A (rs776746) RUO 60, 96

BA224 SLCO1B1 PCR Kit Real Time PCR test for detection of SLCO1B1 gene polymorphism T37041C (Val174Ala; rs4149056) RUO 60

Tacrolimus (FK-506 or Fujimycin) Resistance

Statins Resistance

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3.5 Genetic Diseases Order number Product name Legal Status Tests/SizeIntended use

BA236 IL28B Polymorphism PCR KitReal Time PCR tests for detection and genotyping of polymorphisms C->T (rs12979860) or T->G (rs8099917) in the human gene coding for Interleukin 28B which are predictive of response to antiviral treatment

48,96

BA482 IL28B-ITPA PCR Kit

Kit for simultaneous detection and genotyping of polymorphisms in the genes for IL28B and inosine triphosphate pyrophosphatase (ITPA) leading to reduction of hemoglobin during peg-interferon plus ribavirin combination therapy for patients with chronic hepatitis C virus infection by Reverse Line Blot

20

Genetic Polymorphisms Involved in Anti-Viral Treatment

BA232 TAS PCR KitPCR Test for the detection of 13, 18, 21 chromosome trisomy and sexual aneuploidies by multiplex PCR with fluorescent primers and subsequently DNA fragment analysis by automatic sequencer.

25

Aneuploidies

BA233 Lactose Intolerance PCR KitReal Time PCR test for Lactose Intolerance detection of the C/T (-13910) polymorphism within the regulatory region of the lactase persistence gene (LCT)

50, 96

Lactose Intolerance

BA481 ACD PCR KitReal Time PCR test for the screening of single nucleotide polymor-phism of codon124 (exon4) which is coding igh3 gene in Avellino Corneal disease

12, 25, 50, 96, 100

Avellino Corneal Disease

BA238 AZF PCR Kit

Multiplex PCR/Strip test for the detection of microdeletions in the azoospermia factor (AZF) of the Y chromosome causing azoospermia and oligospermia. For detection of deletions at AZF locus, target regions: sY84, sY86, DFFRY, DBY, sY95, sY117, sY125, sY127, sY134, sY254, sY255, ZFX/ZFY, SRY. Internal control: ZFX/ZFY

8, 12, 16, 25, 60, 100

Male Infertility

4. HLA AND BLOOD GROUP TYPING

BA239 HLA-A PCR Kit End-point Fluorescence PCR test for detection of HLA-A low resoluti-on, 24 rxn/test - 10

BA240 HLA-B PCR Kit End-point Fluorescence PCR test for detection of HLA-B low resolu-tion, 48 rxn/test - 10, 20

BA241 HLA-C PCR Kit End-point Fluorescence PCR test for detection of HLA-C low resolu-tion, 24 rxn/test - 10

BA242 HLA-ABC PCR Kit End-point Fluorescence PCR test for detection of HLA-ABC low resolution, 96 rxn/test - 10

BA243 HLA-ABDR PCR Kit End-point Fluorescence PCR test for detection of HLA-ABDR low resolution, 96 rxn/test - 10

BA244 HLA-DR PCR Kit End-point Fluorescence PCR test for detection of HLA-DRB low resolution, 24 rxn/test - 10

BA245 HLA-DRB1 PCR Kit End-point Fluorescence PCR test for detection of HLA-DR B1 low resolution, 48 rxn/test - 10, 20

BA246 HLA-DRDQ PCR Kit End-point Fluorescence PCR test for detection of HLA-DRB/DQB low resolution, 32 rxn/test - 10, 30

BA247 HLA-DRDQDP PCR Kit End-point Fluorescence PCR test for detection of HLA-DRB/DQB low resolution, 88 rxn/test - 10

BA483 HLA-A29 PCR Kit Real-Time PCR test for detection of HLA-A*29 group of alleles - 48

BA484 HLA-B57 PCR Kit Real Time PCR test for the time HLA-B*57:01 allele screening - 48, 100

4.1 HLA / HPA Typing Order number Product name Legal Status Tests/SizeIntended use

BA485 HLA Narcolepsy PCR Kit Real-Time PCR test for the detection of HLA-DQB1*06:02 group of alleles - 48

Narcolepsia

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BA4788 HLA-DQ PCR KitReal Time PCR test for the analysis of HLA-DQ2 and HLA-DQ8 gene-tic regions by real time detection of the alleles DQA1*05, DQB1*02 and DQB1*0302. Distribution of these alleles gives an indication of a genetic predisposition for celiac disease (gluten intolerance)

12, 20, 48, 50, 60, 96

Celiac Disease (Gluten Intolerance)

BA486 HLA Behcet’s Disease PCR Kit Real-Time PCR test for the detection of HLA-B*51 & B*52 groups of alleles - 24, 48

BA487 HLA-B5/57 PCR KitEnd-point Fluorescence PCR test for detection of HLA-B*51 (associated with Morbus Behçet), HLA-B*57 (associated with HSR to Abacavir)

-

Morbus Behçet

BA249 HPA PCR Kit End-point Fluorescence PCR test for detection of for typing HPA-1,2,3,4,5,6,9 and 15 alleles, 9 rxn/test - 10, 48

BA250 HPA-1 a/b PCR Kit End-point Fluorescence PCR test for detection of for screening HPA-1 a/b alleles, 1 rxn/test - 48, 96

HPA Typing

BA489 HLA-B*27/ CYP2D6*4 PCR Kit Real Time PCR test for detection of the HLA-B and the CYP2D6*4 allels 12, 60

BA235 HLA-B27 PCR Kit

Real Time PCR test or End-point Fluorescence PCR test for the analysis of the HLA-B27 genetic region that is highly associated with inflammatory rheumatic diseases, especially ankylosing spondyli-tis (Bechterew‘s disease), Reiter‘s syndrome, anterior uveitis and inflammatory bowel disease.

12, 25, 48, 50, 96, 100

BA490 HLA-DRB1 „Shared Epitope“ QKRAA/ QRRAA/ RRAA PCR Kit

Real Time PCR test for detection of the „Shared Epitope“ QKRAA/QRRAA/RRRAA of rheumatoid arthritis in all known HLA-DRB1 allels, and discrimination between homozygous and heterozygous carriers

12, 60

Rheumatoid Arthritis / Ankylosing spondylitis

BA251 RBC-ABO basic PCR Kit End-point Fluorescence PCR test for ABO detection (01, 02, B, A, A2) ,17 rxn/test - 10, 40

BA252 RBC-Typing PCR Kit End-point Fluorescence PCR test for typing of various human red cell blood group alleles, 32 rxn/test - 10, 30

BA253 RBC-CDE PCR Kit End-point Fluorescence PCR test for detection of Rhesus and D Variant, 24 rxn/test - 10, 40

BA254 RBC-weak/ variant PCR Kit End-point Fluorescence PCR test for detection of Rhesus D weak and Dell, 16rxn/test - 10, 48

BA255 RBC-Rare PCR Kit End-point Fluorescence PCR test for detection of rare blood group alleles, 32 rxn/test - 10, 30

BA256 RBC-D screen PCR Kit End-point Fluorescence PCR test for detection of RHD-Exon 3, 5 and 10, 1 rxn/test - 48

BA257 RBC-Vel Screen PCR Kit End-point Fluorescence PCR test for detection of Vel+ and Vel-, 2 rxn/test - 48

BA258 RBC-KKD PCR Kit End-point Fluorescence PCR test for detection of Kell/Kidd/Duffy, 14 rxn/test - 10

BA259 RBC-MNS PCR Kit End-point Fluorescence PCR test for detection of MNSs, Vw and Mg, 7 rxn/test - 10

4.2 Blood Group Typing Order number Product name Legal Status Tests/SizeIntended use

5. FOOD ANALYSIS

BA260 Beef Meat PCR Kit Real Time PCR test for detection of beef meat DNA in food - 100

BA261 Black/white Halibut Meat PCR Kit Real Time PCR test for detection of halibut meat DNA in food - 100

5.1 Identification of Meat Species in FoodOrder number Product name Legal Status Tests/SizeIntended use

4.1 HLA / HPA Typing Order number Product name Legal Status Tests/SizeIntended use

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BA275 Acetic acid bacteria PCR Kit Real Time PCR test for detection of Acetic acid bacteria DNA - 100

BA276 Alicyclobacillus ssp. PCR Kit Real Time PCR test for detection of Alicyclobacillus DNA - 100

BA277 Bottom fermented yeast PCR Kit Real Time PCR test for detection of bottom fermented yeast DNA - 100

BA278 Dekkera anomala PCR Kit Real Time PCR test for detection of D. anomala DNA - 100

BA279 Dekkera bruxellensis PCR Kit Real Time PCR test for detection of D. bruxellensis DNA - 100

BA280 Lactobacillus brevis/ L. brevisimilis PCR Kit Real Time PCR test for detection of L. brevis/ L. brevisimilis DNA - 100

BA281 Lactobacillus buchneri/ parabuchneri PCR Kit Real Time PCR test for detection of L. buchneri/ parabuchneri DNA - 100

BA282 Lactobacillus casei/ L. paracasei/ L. rhamnosus/ L. zeae PCR Kit

Real Time PCR test for detection of L. casei/L. paracasei /L. rhamnosus/L. zeae DNA - 100

BA283 Lactobacillus collinoides/ paracollinoides PCR Kit

Real Time PCR test for detection of L. collinoides/ paracollinoides DNA - 100

BA284 Lactobacillus coryniformis PCR Kit Real Time PCR test for detection of L. coryniformis DNA - 100

BA285 Lactobacillus lindneri PCR Kit Real Time PCR test for detection of L. lindneri DNA - 100

BA286 Lactobacillus perolens PCR Kit Real Time PCR test for detection of L. perolens DNA - 100

BA262 Camel Meat PCR Kit Real Time PCR test for detection of camel meat DNA in food - 100

BA263 Cat & dog Meat PCR Kit Real Time PCR test for detection of cat & dog meat DNA in food - 100

BA264 Chicken Meat PCR Kit Real Time PCR test for detection of chicken meat DNA in food - 100

BA265 Horse/Donkey Meat PCR Kit Real Time PCR test for detection of horse/donkey meat DNA in food - 100

BA266 Pork Meat PCR Kit Real Time PCR test for detection of pork meat DNA in food - 25, 100

BA267 Rabbit Meat PCR Kit Real Time PCR test for detection of rabbit meat DNA in food - 100

BA268 Turkey Meat PCR Kit Real Time PCR test for detection of turkey meat DNA in food - 100

BA269 Waterbuffalo Meat PCR Kit Real Time PCR test for detection of waterbuffalo meat DNA in food - 100

5.3 Food PathogensOrder number Product name Legal Status Tests/SizeIntended use

5.1 Identification of Meat Species in FoodOrder number Product name Legal Status Tests/SizeIntended use

BA270 GMO Cabbage (Ogura) PCR Kit Real Time PCR test for detection or quantification of GMO Ogura (CMS) - 100

BA271 GMO Canola PCR Kit Real Time PCR test for detection or quantification of GMO Canola (GT 73, T45, GT73, MS8) - 100

BA272 GMO Corn PCR Kit Real Time PCR test for detection or quantification of GMO Corn (Bt176, Bt11, T25, MON810, MON 863, GA 21, NK 603, 35S, 3272) - 100

BA273 GMO Rice PCR Kit Real Time PCR test for detection or quantification of GMO Rice (P35S, LibertyLink 601, Bt63) - 100

BA274 GMO Soya PCR Kit Real Time PCR test for detection or quantification of GMO Soya (RoundUp Ready, 35S, RR2Y, A2704-12) - 100

5.2 Genetically Modified Organisms (GMO) Order number Product name Legal Status Tests/SizeIntended use

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BA287 Lactobacillus plantarum/ paraplantarum/ L. pentosus PCR Kit

Real Time PCR test for detection of L. plantarum/ paraplantarum/ L. pentosus DNA - 100

BA288 Lactobacillus rossiae PCR Kit Real Time PCR test for detection of L. rossiae DNA - 100

BA289 Lactobacillus/Pediococcus PCR Kit Real Time PCR test for detection of Lactobacillus/Pediococcus DNA - 100

BA290 Legionella ssp. PCR Kit Real Time PCR test for detection and quantification of Legionella spp. - 70

BA291 Leuconostoc citreum PCR Kit Real Time PCR test for detection of L. citreum DNA - 100

BA292 Megasphaera cerevisiae PCR Kit Real Time PCR test for detection of M. cerevisiae DNA - 100

BA293 Oenococcus oeni PCR Kit Real Time PCR test for detection of O. oeni DNA - 100

BA294 Pectinatus cerevisiiphilus PCR Kit Real Time PCR test for detection of P. cerevisiiphilus DNA - 100

BA295 Pectinatus frisingensis PCR Kit Real Time PCR test for detection of P. frisingensis DNA - 100

BA296 Pectinatus spp. PCR Kit Real Time PCR test for detection of Pectinatus spp. DNA - 100

BA297 Pedicoccus damnosus PCR Kit Real Time PCR test for detection of P. damnosus DNA - 100

BA298 Pichia anomala PCR Kit Real Time PCR test for detection of P. anomala DNA - 100

BA299 Pichia membranaefaciens PCR Kit Real Time PCR test for detection of P. membranaefaciens DNA - 100

BA302 Saccharomyces diastaticus PCR Kit Real Time PCR test for detection of S. diastaticus DNA - 100

BA301 Salmonella differentiation PCR KitReal Time PCR test for detection of S. typhi, S. paratyphi, Salmonella H1 flagellar antigen types (S. stanley, S. isangi, S. muenchen, S. gaminara, S. utrecht)

- 50

BA300 Salmonella PCR Kit Real Time PCR test for detection of pathogenic Salmonella ssp. DNA that causes typhoid fever, paratyphoid fever and foodborne illness Nordval 100

BA303 Top fermented yeast PCR Kit Real Time PCR test for detection of top fermented yeast DNA - 100

5.3 Food PathogensOrder number Product name Legal Status Tests/SizeIntended use

BA491 Almond Allergen PCR Kit Real Time PCR test for qualitative detection of Almond DNA - 100

BA492 Cashew Allergen PCR Kit Real Time PCR test for qualitative detection of Cashew DNA - 100

BA493 Celery Allergen PCR Kit Real Time PCR test for qualitative detection of Celery DNA - 100

BA494 Crustaceans Allergen PCR Kit Real Time PCR test for qualitative detection of Crustaceans DNA - 100

BA495 Fish Allergen PCR Kit Real Time PCR test for qualitative detection of Fish DNA - 100

BA496 Gluten Allergen PCR Kit Real Time PCR test for qualitative detection of DNA in gluten-con-taining cereals from wheat, barley, rye, oat, spelt and kamut - 100

BA497 Hazelnut Allergen PCR Kit Real Time PCR test for qualitative detection of Hazelnut DNA - 100

BA498 ID Brazil Nut Allergen PCR Kit Real Time PCR test for detection of Brazil nut DNA according to directive (EC) 1169/2011 - 100

BA499 ID Macadamia Allergen PCR Kit Real Time PCR test for detection of Macadamia DNA according to directive (EC) 1169/2011 - 100

5.4 Food Allergens Order number Product name Legal Status Tests/SizeIntended use

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BA600 ID Pecan Allergen PCR Kit Real Time PCR test for detection of Hazelnut DNA according to directive (EC) 1169/2011 - 100

BA501 Lupin Allergen PCR Kit Real Time PCR test for qualitative detection of Lupin DNA - 100

BA502 Molluscs Allergen PCR Kit Real Time PCR test for qualitative detection of Molluscs DNA - 100

BA503 Mustard Allergen PCR Kit Real Time PCR test for qualitative detection of Mustard DNA - 100

BA504 Peanut Allergen PCR Kit Real Time PCR test for qualitative detection of Peanut DNA - 100

BA505 Pistachio Allergen PCR Kit Real Time PCR test for qualitative detection of Pistachio DNA - 100

BA506 QUANT Celery Allergen PCR Kit Real Time PCR test for quantitative detection of Celery DNA - 100

BA507 QUANT Gluten Allergen PCR Kit Real Time PCR test for quantitative detection of Hazelnut DNA - 100

BA508 QUANT Hazelnut Allergen PCR Kit Real Time PCR test for quantitative detection of Hazelnut DNA - 100

BA509 QUANT Lupin Allergen PCR Kit Real Time PCR test for quantitative detection of Lupin DNA - 100

BA510 QUANT Peanut Allergen PCR Kit Real Time PCR test for quantitative detection of Peanut DNA - 100

BA511 QUANT Pistachio Allergen PCR Kit Real Time PCR test for quantitative detection of Pistachio DNA - 100

BA512 QUANT Sesame Allergen PCR Kit Real Time PCR test for quantitative detection of Sesame DNA - 100

BA513 QUANT Soya Allergen PCR Kit Real Time PCR test for quantitative detection of Hazelnut DNA according to directive (EC) 1169/2011 detection of Hazelnut DNA - 100

BA514 QUANT Walnut Allergen PCR Kit Real Time PCR test for quantitative detection of Gluten DNA - 100

BA515 Sesame Allergen PCR Kit Real Time PCR test for qualitative detection of Sesame DNA - 100

BA516 Soya Allergen PCR Kit Real Time PCR test for qualitative detection of Soya DNA - 100

BA517 Walnut Allergen PCR Kit Real Time PCR test for qualitative detection of DNA from walnut - 100

5.4 Food AllergensOrder number Product name Legal Status Tests/SizeIntended use

BA304 Water Microbial Concentration KitKit for concentration of the microbes present in water samples, for later testing for the presence of bacteria by PCR techniques, incl. membranes and cartridges.

- 35

5.5 Concentration of Water SamplesOrder number Product name Legal Status Tests/SizeIntended use

BA305 Beer Differentiation PCR Kit

Multiplex Real Time PCR screening test for Differentiation of beer spoilage bacteria and yeast in beer and beer mixing drinks. The following bacteria and yeast are differentiated: L. acetotolerans, L. backii, L. brevis/L. brevisimilis/L. parabrevis, L.lindneri, L. casei/ L. paracasei, L. buchneri/L. parabuchneri, L. collinoides/L. paracolli-noides, L. perolens/L. harbinensis, L. plantarum/L. paraplantarum, L. coryniformis, L. rossiae, Pediococcus spp. (P. acidilactici, P. parvulus, P. inopinatus, P. pentosaceus, P. damnosus), P. claussenii, P. damnosus, Pektinatus spp., Megasphaera spp., Enterobacteriaceae, S.diastaticus, Pichia anomala.

- 96

BA306 Wine Screening PCR KitReal Time PCR multiplex screening kit which detects Lactobaccillus, Pedioccous, Oenococcus oeni , Bacteria forming acetic acid, and yeasts

- 50

5.6 Beer and Wine DifferentiationOrder number Product name Legal Status Tests/SizeIntended use

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BA316 AI H5N1 RT-PCR Kit Real Time PCR test for semi-quantitative detection of Avian Influenza virus H5N1 RNA - 60, 120

BA317 AI H5N2 RT-PCR Kit Real Time PCR test for detection of Avian Influenza virus H5N2 RNA - 25

6.3 PoultryOrder number Product name Legal Status Tests/SizeIntended use

6. ANIMAL RELATED DISEASES / ZOONOSES

BA518 Bovine Coronavirus RT-PCR Kit Real Time PCR Kit for detection of RNA of the N gene of the bovine coronavirus (BCoV) - 50, 100

BA518 Bovine Torovirus RT-PCR Kit Real Time PCR Kit for detection of RNA of the M gene of the bovine torovirus (BToV) - 50, 100

BA308 Bovine Virusdiarrhoe Virus (BVDV) RT-PCR Kit Real Time PCR test for detection of BVDV RNA FLI 50, 100

BA519 BVDV/BDV RT-PCR Kit Multiplex Real Time PCR test for detection of BVDV and BDV RNA - 48, 96

BA309 Foot-and-Mouth Disease Virus (FMDV) RT-PCR Kit

Real Time PCR test for detection of Foot-and-Mouth Disease Virus (FMDV) RNA - 25

BA520 Mastitis PCR Kit (4, 8 or 12 pathogens)

Multiplex Real Time PCR test for detection of 48 or 12 pathogens including Staphylococcus aureus, CNS, Beta-Lactamase gene (Sta-phylococci), Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, Mycoplasma bovis, Mycoplasma species, Proto-theca, E.coli, Klesiella, Enterococcus and Lacotococcus lactis

- 386

BA310 Mycobacterium paratuberculosis IMS PCR Kit Real Time PCR test for detection of Mycobacterium paratuberculosis IMS DNA - 100

BA311 Schmallenberg Virus real time RT-PCR Kit Real Time PCR test for detection of Schmallenberg Virus RNA FLI 100

BA312 African Swine Fever (ASF) PCR Kit Real Time PCR test for detection of ASF DNA - 50, 60, 120

BA313 Classical Swine Fever Virus (CSFV) RT-PCR Kit Real Time PCR test for detection of CSFV RNA - 50

BA521 PCMV PCR Kit Real Time PCR Kit for detection of the DPOL gene of the porcine cytomegalovirus (PCMV) - 50, 100

BA522 PCV2 PCR Kit Real Time PCR Kit for detection of the ORF1 of the porcine circovirus type 2 (PCV2) including the three genotypes A, B and C - 50, 100

BA523 PEDV & SDCV PCR KitReal Time PCR Kit for detection and differentiation of RNA of the N gene of the porcine epidemic diarrhea virus (PEDV) and of the S region of the transmissible gastroenteritis virus (TGEV)

- 50, 100

BA524 PEDV PCR Kit Real Time PCR Kit for detection of RNA of the N gene of the porcine epidemic diarrhea virus (PEDV) - 50, 100

BA525 PHEV RT-PCR Kit Real Time PCR Kit for detection of RNA of the N gene of the porcine hemagglutinating encephalomyelitis virus (PHEV) - 50, 100

BA526 Porcine Parvovirus PCR Kit Real Time PCR Kit for detection of the NS1 gene of the porcine parvovirus (PPV) - 50, 100

BA314 Porcine reproductive and respiratory syndro-me virus (PRRSV) RT-PCR Kit

Real Time PCR test for detection of PRRSV RNA - 25, 100

BA527 SDCV RT-PCR Kit Real Time RT-PCR Kit for detection of RNA of the 3’UTR of the swine delta coronavirus (SDCV) - 50, 100

BA528 SIV RT-PCR Kit Real Time RT-PCR Kit for detection of RNA of the matrix protein gene of the Swine Influenza A (SIV) - 50, 100

6.1 Cattle / RuminantsOrder number Product name Legal Status Tests/SizeIntended use

6.2 SwineOrder number Product name Legal Status Tests/SizeIntended use

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BA318 AI H5N7 RT-PCR Kit Real Time PCR test for detection of Avian Influenza virus H5N7 RNA - 25

BA529 Gallid Herpesvirus 2 (GaHV-2)PCR Kit Real Time PCR test for detection of Gallid herpesvirus 2 (Marek`s Disease Virus, MDV) DNA - 150

BA319 Infectious Bronchitis virus (IBV) RT-PCR Kit Real Time PCR test for detection of IBV RNA - 100

BA320 Infectious Bursal Disease Virus (IBDV) RT-PCR Kit

Real Time PCR test for detection of IBDV RNA - 100, 150

BA321 Infectious Laryngotracheitis Virus (ILT) PCR Kit

Real Time PCR test for detection of ILT DNA - 100

BA323 Mycobacterium tuberculosis avium PCR Kit Real Time PCR test for detection of M. tuberculosis avium DNA - 32, 96

BA324 Mycoplasma iowae PCR Kit Real Time PCR test for detection of Mycoplasma iowae DNA - 100

BA322 Newcastle Disease Virus (NDV) RT-PCR Kit Real Time PCR test for detection of Newcastle Disease Virus (NDV) RNA - 25

BA325 Canine Babesia PCR Kit Real Time PCR test for detection of Babesia species (Babesia canis & Babesia gibsoni) 32, 96

BA327 Canine Ehrlichia PCR Kit Real Time PCR test for the differentiation of Ehrlichia spec. and Anaplasma spec. 32

BA530 Echinococcus multilocularis PCR Kit Real Time PCR test for detection of the cyclophyllid tapeworm Echinococcus multilocularis DNA - 100

BA532 American foulbrood PCR Kit Real Time PCR test for detection of the 16S rRNA gene of Paeniba-cillus larvae in honey bees - 50, 100

BA533 European foulbrood PCR Kit Real Time PCR test for detection of the 16S rRNA gene of Melisso-coccus plutonius in honey bees - 50, 100

BA534 Foulbrood European & American PCR Kit Multiplex Real Time PCR test for detection of the 16S rRNA gene of Melissococcus plutonius and Paenibacillus larvae - 50, 100

BA332 Equine Babesia PCR Kit Real Time PCR test for detection of Babesia species (Babesia caballi & Babesia equi) DNA 32, 96

BA333 Equine Anaplasma PCR Kit Real Time PCR test for detection of Anaplasma phagocytophilum (also Ehrlichia phagocytophilum, Ehrlichia equi) 32, 96

BA531 Capripoxvirus PCR Kit Real Time PCR Kit for detection of Capripoxvirus via the LSDV116 RNA polymerase subunit (LSDV116) - 150

BA334 Monkeypox Virus PCR Kit Real Time PCR test for detection of Monkeypox Virus DNA - 25

6.3 PoultryOrder number Product name Legal Status Tests/SizeIntended use

6.4 Feline & CanineOrder number Product name Legal Status Tests/SizeIntended use

6.8 Honey BeeOrder number Product name Legal Status Tests/SizeIntended use

6.5 EquineOrder number Product name Legal Status Tests/SizeIntended use

6.6 SheepOrder number Product name Legal Status Tests/SizeIntended use

6.7 PrimatesOrder number Product name Legal Status Tests/SizeIntended use

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BA535 Nosema apis & ceranae PCR KitReal Time PCR test for detection of Nosema apis & ceranae microscopic fungi that typically parasitize insects such as Eastern honey bee

- 50,100

6.9 Animal-Related MycosesOrder number Product name Legal Status Tests/SizeIntended use

BA536 Histomonas meleagridis PCR Kit Real Time PCR test for detection of the 18S rRNA gene of H. meleagridis - 50, 100

BA537 Neospora caninum PCR Kit Real Time PCR test for detection of the mitochondrial NC5 gene of N. caninum - 50, 100

BA538 Trichinella spiralis & britovi PCR Kit Real Time PCR test for detection and differentiation of the internal transcribed spacer of Trichinella spiralis and T. britovi - 50, 100

6.10 Animal-Related ParasitesOrder number Product name Legal Status Tests/SizeIntended use

6.11 Further Animal-related BacteriaOrder number Product name Legal Status Tests/SizeIntended use

BA539 Actinobacillus pleuropneumoniae PCR Kit Real Time PCR test for detection of the apxIVA gene of A. pleuropneumoniae - 50, 100

BA540 Aerococcus viridans PCR Kit Real Time PCR test for detection of the 16S rRNA gene of A. viridans - 50, 100

BA541 Bartonella spp.PCR KitReal Time PCR test for detection of the gltA gene of B. clarridgeiae, B. elizabethae, B. grahamii, B. henselae, B. koehlerae, B. quintana, B. volans and B. washoensis

- 50, 100

BA542 Bordetella bronchiseptica PCR Kit Real Time PCR test for detection of the bfrA gene of B. bronchisep-tica - 50, 100

BA543 Borrelia burgdorferi sensu lato PCR KitReal Time PCR test for detection of the ospA gene of Borrelia species belonging to the Borrelia burgdorferi sensu lato complex (B. spielma-nii is not well detected)

- 50, 100

BA544 Brachyspira PCR Kit Real Time PCR test for single or combined detection of the nox gene of B. hyopneumoniae and/or B. pilosicoli - 50, 100

BA545 Chlamydiaceae PCR KitReal Time PCR test for detection of the 23S rRNA gene of C. muridar-um, C. suis, C. trachomatis, C. abortus, C. caviae, C. felis, C. pecorum, C. pneumoniae and C. psittaci

- 50, 100

BA546 Chlamydophila psittaci/abortus PCR Kit Real Time PCR test for detection of the omp1 gene of C. abortus and C. psittaci - 50, 100

BA547 Clostridium perfringens PCR Kit Real Time PCR test for detection of the 16S rRNA gene of Clostridium perfringens - 50, 100

BA548 Corynebacterium pseudotuberculosis PCR Kit Real Time PCR testfor detection of the pld gene of Corynebacterium pseudotuberculosis - 50, 100

BA549 Enteroococcus ssp. PCR Kit Real Time PCR test for detection of the 23S rRNA gene of Enterococcus species - 50, 100

BA550 Haemophilus parasuis PCR Kit Real Time PCR test for detection of the 16S rRNA gene of H. parasuis - 50, 100

BA551 Lawsonia intracellularis PCR Kit Real Time PCR test for detection of the 16S rRNA gene of L. intra-cellularis - 50, 100

BA552 Leptospira spp. Differentiation PCR KitReal Time PCR test for detection and differentiation of LipL32 gene of pathogenic and 16S rRNA gene of pathogenic and intermediately pathogenic Leptospira species

- 50, 100

BA553 Mannheimia haemolytica PCR Kit Real Time PCR test for detection of the 16S rRNA gene of M. haemolytica - 50, 100

BA554 Mycobacterium avium ssp. Paratuberculosis PCR Kit

Real Time PCR test for detection of the IS900 region of M. avium subspecies paratuberculosis - 50, 100

BA556 Mycoplasma bovis PCR Kit Real Time PCR test for detection of the rpoB gene of M. bovis - 50, 100

BA557 Mycoplasma gallisepticum PCR Kit Real Time PCR test for detection of the mgc2 gene of M. gallisepticum - 50, 100

BA558 Mycoplasma hyopneumoniae PCR Kit Real Time PCR test for detection of the rpoB gene of M. hyopneumoniae - 50, 100

BA559 Mycoplasma hyorhinis PCR Kit Real Time PCR Kit for detection of the rpoB gene of M. hyorhinis - 50, 100

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6.11 Further Animal-related Bacteria Detection AssaysOrder number Product name Legal Status Tests/SizeIntended use

BA560 Mycoplasma suis PCR Kit Real Time PCR test for detection of the 16S rRNA gene of M. suis - 50, 100

BA561 Mycoplasma synoviae PCR Kit Real Time PCR test for detection of the vlhA gene of M. synoviae - 50, 100

BA562 Nocardia spp. PCR Kit Real Time PCR test for detection of the 16S rRNA gene of Nocardia species - 50, 100

BA563 Ornithobacterium rhinotracheale PCR Kit Real Time PCR test for detection of the 16S rRNA gene of Ornithobacterium rhinotracheale - 50, 100

BA564 Pasteurella multocida PCR Kit Real Time PCR test for detection of the 16S rRNA gene of Pasteurella multocida (subspecies P. multocida, P. gallicida, P. septica, P. tigris) - 50, 100

BA565 Pasteurella multocida toxA PCR Kit Real Time PCR test for detection of the toxA gene of toxigenic Pasteurella multocida strains - 50, 100

BA566 Salmonella enterica PCR Kit Real Time PCR test for detection of the invA gene of Salmonella enterica - 50, 100

BA567 Staphylococcus aureus PCR Kit Real Time PCR Kit for detection of the nuc gene of S. aureus - 50, 100

BA568 Staphylococcus ssp. PCR Kit Real Time PCR Kit for detection of the 23S rRNA gene of Staphylo-coccus species - 50, 100

BA569 Streptococcus agalactiae PCR Kit Real Time PCR Kit for detection of the cfb gene of S. agalactiae - 50, 100

BA570 Streptococcus dysgalactiae PCR KitReal Time PCR Kit for detection and differentiation of 23S rRNA gene of S. dysgalactiae and S. canis and of 16S rRNA gene of Streptococcus species except S. canis

- 50, 100

BA571 Streptococcus spp. PCR Kit Real Time PCR Kit for detection of the 23S rRNA gene of Streptococcus species - 50, 100

BA572 Streptococcus uberis PCR Kit Real Time PCR Kit for detection of the ITS2 region of S. uberis - 50, 100

BA573 Trueperella pyogenes PCR Kit Real Time PCR Kit for detection of the 16S rRNA gene of T. pyogenes - 50, 100

BA574 EMCV (Encephalomyocarditis-Virus) RT-PCR Kit

Real Time PCR Kit for detection of RNA of the 3´UTR of the encephalomyocarditis virus (EMCV) - 50, 100

BA575 Rabies Virus RT-PCR Kit Real Time PCR Kit for detection of Rabies RNA - 50, 100

6.12 Further Animal-Related Virus Detection AssaysOrder number Product name Legal Status Tests/SizeIntended use

7. NUCLEIC ACIDS PURIFICATION

BA576 Advanced food and feed DNA isolation Kit (highly processed food & feed)

Advanced kit for efficient DNA preparation from highly processed food and feed - 50

BA577 Basic food and feed DNA isolation Kit (Plants) Basic kit for efficient DNA preparation from food and feed (Plants) - 100

BA335 BEX12 Ready DNA Bead Kit For automated DNA isolation with the BEX12 Bead Extraction System RUO 180

BA336 Blood DNA Mini Purification KitGeneric system for the isolation and purification of DNA from fresh, or frozen human or animal blood, buffy coat, and bone marrow, based on micro column technology or magnetic beads

50, 96

BA337 Clean Water DNA Extraction Kit (incl. Filtration membranes)

System for the extraction and purification of DNA from water samples in which it is assumed that the microbe population is low, Filtration membranes (100 units)

RUO 70

BA338 Dirty Water DNA Extraction Kit (incl. Filtration membranes)

System for the extraction and purification of DNA from “dirty” water samples (for example, water from refrigeration towers). RUO 70

7.1 DNA PreparationOrder number Product name Legal Status Tests/SizeIntended use

32 bioactiva

BA340 Kit for isolation of DNA fragmentsSystem for ultra fast purification and concentration of DNA fragments after PCR reactions, restriction digestion, ligation, cDNA synthesis

RUO 50, 250

BA341 Kit for isolation of DNA fragments from gels and PCR-clean-up

System for Gel and PCR Clean-up including Clean-up Columns, Collection Tubes, buffers RUO 250

BA339 Kit for isolation of DNA from microorganisms System for isolation of microbial DNA from bacteria, yeasts and fungi RUO 50

BA342 Plasmid DNA Mini, Midi or Maxi Kit System for purification of ultrapure supercoiled plasmid DNA with high yield. transfection-grade DNA 25, 100

BA343 Tissue DNA Purification KitSystem for purification of high quality DNA from human whole blood, bone marrow, buffy coat, buccal cells, body fluids, cultured cells, tissue, mouse tail, yeast, bacteria

50

BA344 Virus DNA Purification Kit Generic system for the isolation and purification of viral DNA based on micro column technology 50, 250

BA345 Blood RNA Mini Purification KitGeneric system for the isolation and purification of total RNA from blood from up to 400 μl of sample based on micro column technology

50

BA348 Total RNA Purification Kit (from cells, tissues) Generic system for the isolation and purification of total RNA from cells, tissues etc. based on micro column technology 50, 250

BA346 Universal RNA Mini Kit Generic system for isolation of total RNA from human and animal cells, tissue samples, paraffin embedded tissue, whole blood samples 50

BA347 Virus RNA Purification Kit Generic system for the isolation and purification of viral RNA based on micro column technology 50, 250

BA578 M-MLV Reverse TranscriptaseMoloney Murine Leukemia Virus Reverse Transcriptase (M-MLV RT), RNA-dependent DNA polymerase that can be used in cDNA synthesis with long messenger RNA templates (>5kb); 200 U/µL

- 10,000 U

BA579 Recombinant Ribonuclease Inhibitor Recombinant 50 kDa proteins that inhibit RNase A family and human placental RNases by noncovalently binding to RNases - 2,500 U

BA353 Reverse TranscriptaseSuitable for first-strand cDNA synthesis, cDNA library construc-tion, and the production of templates for RT-PCR analysis of gene expression

- 4 x 10,000 U

BA354A Deoxynucleoside 5‘-triphosphates I Set of 4 dNTPs 10 mM, 4 x 10 mM - 200 µL, 1 mL

BA354B Deoxynucleoside 5‘-triphosphates II Set of 3 + 1 dNTPs, with dUTP, 4 x 100 mM - 200 µL, 1 mL

BA355 Uracil-DNA Glycosylase (UDG) For control of carry-over contamination in PCR, fully inactivated without retaining residual activity - 200, 1000 U

BA580 50x ROX solutionROX passive reference dye, for use with low ROX (7500 Fast, StepOne) and high ROX (ABI PRISM® 7000/7300/7700) requiring ABI real time PCR platforms; 50x conc.M;

- 1x 0.20 mL

7.1 DNA PreparationOrder number Product name Legal Status Tests/SizeIntended use

7.2 RNA PreparationOrder number Product name Legal Status Tests/SizeIntended use

8.2 Reverse TranscriptionOrder number Product name Legal Status Tests/SizeIntended use

8.3 PCR AdditivesOrder number Product name Legal Status Tests/SizeIntended use

8. PCR REAGENTS & ADDITIVES

BA351 Taq DNA Polymerase (hot start) Recombinant thermostable DNA polymerase, heat activatable, 5 U/µL - 100, 500, 2500, 10,000 U

BA352 Taq Master Mix Set contains Polymerase & dNTPs, 25 µL PCR reactions - 200, 5x200 rxn

8.1 PCR / RT-PCR Enzymes & MixesOrder number Product name Legal Status Tests/SizeIntended use

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8.4 DNA ElectrophoresisOrder number Product name Legal Status Tests/SizeIntended use

BA581 1 kb DNA Ladder Molecular DNA (1 kb) marker for electrophoresis, ready-to-use - 50 μg

BA582 100 bp DNA Ladder Molecular DNA (100 bp) marker for electrophoresis, ready-to-use - 50 or 250 µg

BA583 50 bp DNA Molecular DNA (50 bp) marker for electrophoresis, ready-to-use - 50 or 250 µg

BA584 TAE buffer 10-fold concentration Buffer for agarose gel electrophoresis - 1 L

BA585 TBE 5-fold concentration Buffer for PAA gel electrophoresis - 1 L

BA586 Gel loading buffer, ready-to-use For electrophoresis, 1x conc. Gel loading buffer (with Glycerin), ready-to-use, DNase-free - 5x1 mL

BA587 Ethidium bromide For electrophoresis, for fluorescence staining of nucleic acids in agarose and PAA gels; , 1% or 0.07% (ready for use), - 10 mL

BA588 SYBR® Green I For electrophoresis, for fluorescence staining of nucleic acids in agarose and PAA gels, 10,000 x concentrate in DMSO - 500 µL

BA589 Eva Green® Fluorescence dye, 100x-conc. For electrophoresis, for fluorescence staining of nucleic acids in agarose and PAA gels, sufficient to stain about 500 lanes - 500 µL

9. PCR LAB EQUIPMENT

BA356 Advanced thermal cyler96-well block, Peltier-based, 6.5 inch, 262, 144 color LCD display and touch screen, heating/cooling ramp rate 4°C/sec, 30°C gradient function, 220 V

1

BA590 Interchangeable blocks For 96 x 0.2 mL, 30 x 0.5 mL, 48 x 0.2 mL,; and for standard in situ plates 1

BA357 Standard thermal cyler 30, 48, 60, 96, 384-well block, Peltier-based, 320*240 LCD,5.7 inch display, 220 V 1

BA591 Gel Documentation System Gel Documentation System including 18 MP Camera, transilluminator with sliding table,UV shield, analysis software; 1

BA592 Horizontal electrophoresis systems (for mini, midi, maxi agarose gels)

Horizontal chambers for DNA and RNA separation, including: UV-transparent gel casting tray, combs, coloured loading strips 1

BA593 Power Supply Power Supply for Electrophoresis Units 300 V, 400 mA 1

BA358 FluoVista System FluoVista Analyzer incl. PC System, Monitor, Barcode Reader, IQOQ Kit and software package 1

BA359 FluoVista Calibration System 1

BA594 Real-Time PCR System 2 channels Real Time PCR Detection System, 96 x 0.2 mL, 2 channels, bluetooth, F1: FAM, SYBR Green I; F2: VIC, HEX, TET, JOE 1

9.1 Thermal CyclerOrder number Product name Legal Status Tests/SizeIntended use

9.3 DNA Electrophoresis / PCR Product DetectionOrder number Product name Legal Status Tests/SizeIntended use

9.2 Endpoint Fluorescence DetectionOrder number Product name Legal Status Tests/SizeIntended use

9.4 Real Time PCR Instruments & EquipmentOrder number Product name Legal Status Tests/SizeIntended use

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BA595 Real-Time PCR System 4 channelsReal Time PCR Detection System, 96 x 0.2 mL, 4 channels, bluetooth, F1: FAM, SYBR Green I; F2: VIC, HEX, TET, JOE; F3: ROX, TEXAS-RED; F4: Cy5

1

BA360 Real-Time PCR System 5 channels, Fixed Real Time PCR Detection System with 5 channels (SYBR/FAM, HEX, ROX, CY3, CY5), 2-year base warranty sold with the instrument 1

BA596 Real-Time PCR System 6 channelsReal Time PCR Detection System, 96 x 0.2 mL, 6 channels, bluetooth, F1: FAM, SYBR Green I; F2: VIC, HEX, TET, JOE; F3: Cy3, NED, TAMRA; F4: ROX, TEXAS-RED; F5: Cy5; F6: Cy5.5

1

BA597 Real-Time PCR System 8 channelsReal Time PCR Detection System, 96 x 0.2 mL, 8 channels, bluetooth, F1: FAM, SYBR Green I; F2: VIC, HEX, TET, JOE; F3: Cy3, NED, TAMRA; F4: ROX, TEXAS-RED; F5: Cy5; F6: Cy5.5, F7, F8 for customized applications

1

BA361 Desktop DNA Analyzer2 channels (SYBR/FAM, ROX) Instrument including user manual, 1 accessory kit, CD with Graphing Software, Tube Rack & Centrifuge Adaptors; 1-year base warranty sold with the instrument.

1

BA362 Automated DNA-Extraction BEX12 Bead Extraction System for up to 12 samples, 250 µL extraction volume 1

BA363 Magnetic Particle ProcessorAutomated low-throughput sample preparation system for proces-sing volumes up to 1 mL, supports 15 processed samples per run, Integrated barcode reader for sample ID

1

BA365 ELISA Reader ELISA Reader, 8 Channel 1

BA366 ELISA Washer Elisa Microplate Washer, 8 or 96-well plates or strips 1

BA367A Micropipettes Fix Digital Micropipettes, all sizes 1

BA367B Variable Digital Micropipettes, all sizes 1

BA368A Cooled Incubators 53 L, 108 L, 256 L, 416 L, 749 L 1

BA368B Incubator, Basic 32 L, 39 L, 53 L, 108 L 1

BA598 DNA Blot Processor Compact and stand-alone instrument for automatic processing of hybridization tests, Maximal number of strips: 30 or 48 1

BA599 Robotic Blot Processor

Complete automation of strip assays - from sample preparation to result, up to 48 samples per run, Integrated barcode reader for sample ID, integrated PC for connection to LIMS and Interpretation Software, volume range 10 μL to 2.5 mL, pressure sensing for sample level detection in sample tubes, 100-240V / 50-60Hz

1

BA364 Pipetting Unit For automated PCR setup 1

9.4 Real Time PCR Instruments & EquipmentOrder number Product name Legal Status Tests/SizeIntended use

9.5 Automated Nucleic Acids ExtractionOrder number Product name Legal Status Tests/SizeIntended use

9.8 ELISA EquipmentOrder number Product name Legal Status Tests/SizeIntended use

9.9 PipettesOrder number Product name Legal Status Tests/SizeIntended use

9.10 IncubatorsOrder number Product name Legal Status Tests/SizeIntended use

9.7 DNA Blot ProcessingOrder number Product name Legal Status Tests/SizeIntended use

9.6 Automated Liquid HandlingOrder number Product name Legal Status Tests/SizeIntended use

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BA370 ThermoCell Mixing BlockTemp. Setting Range 0 ~ 105°C, Temp. Control Range RT-1~ 100：, 300 rpm – 1500 rpm (rotation), Standard Blocks 40x1.5 mL, 54x0.5mL, 96x0.2mL, 100-240V / 50-60Hz

1

9.11 ThermoshakerOrder number Product name Legal Status Tests/SizeIntended use

9.12 CentrifugesOrder number Product name Legal Status Tests/SizeIntended use

BA371A Small Benchtop centrifuge Without rotor, 220V 1

BA371B Incl. swing-out rotor 6 x 15 ml, 220 V 1

BA371C Incl. rotor 8x15 ml, 220V 1

BA372A Microlitre centrifuge w/o rotor, max. capacity: 24 x 1,5 / 2 mL 1

BA372B w/o rotor, max capacity: 30 x 1,5 / 2 mL 1

BA372C Without rotor, max capacity: 60 x 1,5 / 2 mL 1

BA373A Refrigerated microlitre centrifuge Without rotor, max capacity: 30 x 1,5 / 2 mL 1

BA373B Without rotor, max capacity: 60 x 1,5 / 2 mL 1

BA374A Benchtop centrifuge Without rotor 220V, max. capacity: 4 x 100 mL, RPM: 6,000 1

BA374B Without rotor, 208-240 V, max. capacity: 4 x 290 mL, RPM: 4,000 1

BA374C Without rotor, 208-240 V, max. capacity: 4 x 600 mL 1

BA374D Without rotor, 208-240 V, max. capacity: 4 x 750 ml 1

BA374E With heating, without rotor, 220V, max. capacity: 4 x 290 mL, RPM: 4,000 1

BA375A Refrigerated Benchtop centrifuge Without rotor, 208-240 V, max. capacity: 4 x 290 mL 1

BA375B Without rotor, 208-240 V, max. capacity: 4 x 600 mL 1

BA375C Without rotor, 208-240 V, max. capacity: 4 x 750 mL 1

BA376 Universal Benchtop centrifuge 220V, max. capacity: 4 x 100 mL, RPM: 18,000 1

BA377 Refrigerated Universal Benchtop centrifuge 220V, max. capacity: 4 x 100 mL, RPM: 18,000 1

9.13 Safety CabinetsOrder number Product name Legal Status Tests/SizeIntended use

BA378A Vertical laminar flow cabinet Compact vertical laminar flow cabinet, type 60 1

BA378B Compact vertical laminar flow cabinet, type 120 1

BA379A Biological safety cabinet Type 90 1

BA379B Type 120 1

BA379C Type 150 1

36 bioactiva

9.13 Safety CabinetsOrder number Product name Legal Status Tests/SizeIntended use

9.14 OvensOrder number Product name Legal Status Tests/SizeIntended use

9.15 AutoclavesOrder number Product name Legal Status Tests/SizeIntended use

9.16 BalancesOrder number Product name Legal Status Tests/SizeIntended use

BA380A Biological safety cabinet Type 60 1

BA380B Type 80 1

BA381A Ductless fume cabinet Type 100 1

BA381B Type 120 1

BA381C Type 150 1

BA381D Type 180 1

BA382A Universal oven Universal oven, Basic, 14 L 1

BA382B Universal oven, Basic, 32 l 1

BA382C Universal oven, Basic, 39 L 1

BA382D Universal oven, Basic, 53 L 1

BA382E Universal oven, Basic, 108 L 1

BA382F Universal oven, Perfect, 108 L 1

BA383A Bench top autoclave Bench top autoclave, 23 L 1

BA383B Bench top autoclave, 23 L with printer 1

BA383C Bench top autoclave, 25 L 1

BA383D Bench top autoclave, 35 L 1

BA381E Bench top autoclave, 50 L 1

BA384A Bench top balances Precision balance, 6000 g, 0.1 g 1

BA384B Bench scale, 3000 g, 1 g 1

BA384C Counting scale, 100 g, 0.001 g 1

BA384D Analytical Balance, 120 g, 0.0001 g 1

BA384E Display device 1

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10. CONSUMABLES FOR REAL-TIME PCR AND CONVENTIONAL PCR

BA385 Optical 96-well Reaction plate For use with all real time PCR instruments and conventional thermal cyclers supporting the 96-well format - 20

BA386 Optical Fast Plate For use with all real time PCR instruments and conventional thermal cyclers supporting the 96-well format - 20

BA387 LightCycler capillaries For use with LightCycler® 1.x and 2.x System - 480

BA388 PCR reaction vessels 0.2 mL For use with block and carousel cyclers supporting the 0.2 mL format - 1000

BA389 PCR reaction vessels 0.1 mL, 4-well/strips with attached cap

For use with Rotor-Gene™ 3000/6000, Rotor-Gene Q - 1000

BA390 SmartCycler Tubes, 25 µL Reaction vessels (25 µl) for SmartCycler® I/II, 20 bags, 50 tubes each - 1000

BA391 Spartan Tubes & Caps Plastic tubes (clear) and caps for use with Spartan DX-12 Desktop DNA Analyzer - 1000

BA392 Low Profile Strips (white), 8-well/strips, 0.2 mL

For use with real time PCR instruments and conventional thermal cyclers supporting the 8-well/strip format - 100

BA393 Optical Cap Strips (clear) Cap strips for use with for use with Low Profile Strips - 100

BA394 Optical Tape Transparent, self-adhesive covers to seal 96-well reaction plates - 100

BA395A Reaction vessels, with or without caps Safe seal tubes, 1.5 mL, clear - 1000

BA395B Reaction vessel, 5 mL - 250

BA395C Safe-lock tubes, 2 mL - 1000

BA395D Reaction vessels, 1.5 mL, clear and amber - 500

BA395E Reaction vessels, 2,0 ml, clear, for screw cap - 500

BA395F Reaction vessels, 0.5 mL, clear, for screw cap - 500

BA396 Screw caps Screw caps, different colours - 500

BA397A Reagent tubes Reagent tubes, 15 mL, sterile - 500

BA397B Reagent tubes, 50 mL, sterile - 500

BA398A Filter tips Filter-Tips, 0.1-10 µL - 960

BA398B Filter-Tips, 10-100 µL - 960

BA398C Filter-Tips, 100-1000 µL - 1000

10.1 PCR TubesOrder number Product name Legal Status Tests/SizeIntended use

10.2 Reaction Vessels / Reagent TubesOrder number Product name Legal Status Tests/SizeIntended use

10.3 Pipette TipsOrder number Product name Legal Status Tests/SizeIntended use

38 bioactiva

BA399 Displacement tips Displacement tips 20 µL - 192

BA400A Combi-Tips Combitip plus Biopur, 0.5 mL - 100

BA400B Combitip plus Biopur, 5 mL - 100

BA400C Combitip plus Biopur, 10 mL - 100

BA400D Combitip plus Biopur, 25 mL - 100

10.3 Pipette TipsOrder number Product name Legal Status Tests/SizeIntended use

1) Caution: Some of the products listed in this catalogue may be not available in selected countries.

Abbreviations

Registration:FLI = Registered with Friedrich-Loeffler-Institut, Germany

Patent Disclaimer

Unless explicitly stated, no license or immunity under any patent is either granted or implied by the sale of any of our products. Bioactiva GmbH does not warrant that the resale or use of its products delivered will not infringe the claims of any patent, trademark or copyright covering the use of the products itself or its use in the operation of any process. Furthermore, the purchaser assumes all risks of patent, trademark or copyright infringement associated with any such use, combination or operation.

IvD Disclaimer

Products for in vitro diagnostic use require CE-Mark in compliance with the European Union Directive 98/79/EC for in vitro diagnostic medical devices. IvD products which do not have the CE mark are intended for research use (RUO) only without any human medical objectives or are intended for such performance evaluations only, which a) do not need exclusive or substantial additional sampling and b) do not require further invasive or strained investigations for the patient and c) do not use the results for a medical hu-man diagnosis unless covered by an established method. In any case, the customer has to fill an accompanying declaration form and to send the signed form back to Bioactiva.

Copyright ©2016 bioactiva diagnostica GmbH. All rights reserved. All company, product and brand names are trademarks or registered trademarks of their respective owners. The information contained in this document is subject to change without notice at any time.

Warranty claims and claims related to the fulfilment of manufacturer`s technical specifications can be only accepted by using original components and consumables. Specifications and order numbers are subject to changes due to further technical development. Purchase is subject to General Terms and Conditions of bioactiva diagnostica GmbH.

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From the North (Kassel/Hannover):Take Autobahn A5 (Kassel-Frankfurt) direction Frankfurt and change to Autobahn A661 direction Bad Homburg. After 1km take exit Bad Homburg.Pass Fresenius on the left, direction city center.

From the South or the West (Airport/Basel/Cologne):Take Autobahn A5 (Frankfurt-Basel) direction Hassel and change to Autobahn A661 direction Bad Homburg. After 1km take exit Bad Homburg.Pass Fresenius on the left, direction city center.

Königstein

Kronberg

Eschborn

661

A3

648

Bad Homburger Kreuz

Eschborner Dreick

NordwestkreuzFrankfurt

Westkreuz Frankfurt

Frankfurter Kreuz

OffenbacherKreuz

A5

A5

Frankfurt am Main

BadHomburg

32

2

1

Bad Homburg Oberursel

Oberursel Nord

456

456

Friedberg

Usingen

66

Oberursel

Who we are

The way to us

bioactiva diagnostica GmbH, founded in 2001 by the biologist Adnan Dawoud, is an experienced and innovativecompany located in Bad Homburg near Frankfurt, Germany. We are a manufacturer and distributor of in-vitrodiagnostics and lab ware. All of the products we manufacture are CE-certified and our customers can be confidentthat they will get pre-selected and optimized quality products. Our working process strictly follows the guidelinesof DIN EN ISO 9001:2008 and ISO 13485:2012 + AC: 2012. Beside our own produced kits we have exclusiveagreements with leading European, American and Asian manufacturers.We can offer moderately priced and high quality products to our customers. Many years of experience and detailedknowledge of the markets put us in the position to help our customers fulfill their very special needs. Direct salesto clinics, specialized labs and hospitals are performed through our subsidiaries as well as through our localpartners in the relevant markets. Due to the excellent position of our headquarters in Bad Homburg (near Frankfurtinternational airport) in the heart of Europe we are able to ship our products worldwide just in time. To maintaina close relationship with our customers and suppliers we regularly exhibit at major trade fairs like Arab Health,Arab Lab and Medica

bioactiva diagnostica GmbHLouisenstraße 137 61348 Bad HomburgGermany

Tel.: +49-6172-17102-0Fax: +49-6172-17102-29E-mail: [email protected]

product list - bioactiva · 2018. 7. 20. · herpesvirus type 7 dna 48, 96 ba036 human herpes virus...

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