Manufacturer's Devices - BIOSYNEX SA

Address:




22 Boulevard Sebastien Brant

ILLKIRCH-GRAFFENSTADEN

Strasbourg

Bas-Rhin 67400

France


Authorised Representative/ UK Responsible Person
Name: Qarad UK Ltd.
Address:

8 Northumberland Ave



Westminster

London WC2N 5BY

England United Kingdom




Code/Term Type
Photometric/spectroscopic immunoassay analyser IVDPhotometric/spectroscopic immunoassay analyser IVDIVD General
Insulin-like growth factor binding protein 1 (IGFBP-1) IVD kit rapid ICT clinicalInsulin-like growth factor binding protein 1 (IGFBP-1) IVD kit rapid ICT clinicalIVD General
HIV1/HIV2 antibody IVD kit rapid ICT clinicalHIV1/HIV2 antibody IVD kit rapid ICT clinicalIVD Annex II List A
HIV1/HIV2 antibody IVD kit rapid ICT self-testingHIV1/HIV2 antibody IVD kit rapid ICT self-testingIVD Annex II List A
Vaginal pH screening IVD kit rapid colorimetric self-testingVaginal pH screening IVD kit rapid colorimetric self-testingIVD Devices for Self-Testing
Luteinizing hormone (LH) IVD kit rapid ICT self-testingLuteinizing hormone (LH) IVD kit rapid ICT self-testingIVD Devices for Self-Testing
Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidTotal human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidIVD Devices for Self-Testing
Gliadin antibody IVD kit rapid ICT self-testingGliadin antibody IVD kit rapid ICT self-testingIVD Devices for Self-Testing
Multiple urine analyte IVD kit rapid colorimetric clinicalMultiple urine analyte IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Medicine chamber spacer reusableMedicine chamber spacer reusableClass I
Multiple Plasmodium species nucleic acid IVD kit nucleic acid technique (NAT)Multiple Plasmodium species nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple faecal parasite nucleic acid IVD kit nucleic acid technique (NAT)Multiple faecal parasite nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Streptococcus pneumoniae antigen IVD kit rapid ICT clinicalStreptococcus pneumoniae antigen IVD kit rapid ICT clinicalIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalBeta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalIVD General
Alpha-fetoprotein/insulin-like growth factor binding protein 1 IVD kit rapid ICT clinicalAlpha-fetoprotein/insulin-like growth factor binding protein 1 IVD kit rapid ICT clinicalIVD General
Beta-haemolytic Group B Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Beta-haemolytic Group B Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Influenza A/B virus antigen IVD kit rapid ICT clinicalInfluenza A/B virus antigen IVD kit rapid ICT clinicalIVD General
Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinicalRespiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinicalIVD General
Ferritin IVD kit fluorescent immunoassayFerritin IVD kit fluorescent immunoassayIVD General
Multiple gastrointestinal virus antigen IVD kit rapid ICT clinicalMultiple gastrointestinal virus antigen IVD kit rapid ICT clinicalIVD General
Bladder tumour associated antigen IVD kit rapid ICT clinicalBladder tumour associated antigen IVD kit rapid ICT clinicalIVD General
Norovirus antigen IVD kit rapid ICT clinicalNorovirus antigen IVD kit rapid ICT clinicalIVD General
Beta-haemolytic Group B Streptococcus nucleic acid IVD controlBeta-haemolytic Group B Streptococcus nucleic acid IVD controlIVD General
Photometric/spectroscopic immunoassay analyser IVDPhotometric/spectroscopic immunoassay analyser IVDClass A
Photometric/spectroscopic immunoassay analyser IVDPhotometric/spectroscopic immunoassay analyser IVDClass A
Multiple faecal parasite nucleic acid IVD reagentMultiple faecal parasite nucleic acid IVD reagentClass A
Beta-haemolytic Group B Streptococcus nucleic acid IVD reagentBeta-haemolytic Group B Streptococcus nucleic acid IVD reagentClass A
Molecular grade lysis reagent IVDMolecular grade lysis reagent IVDClass A