SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0181-031-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Geenius HIV 1/2 Confirmatory Assay with Geenius HIV1/2 Confirmatory Controls
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Directive 98/79/EC: Product design examination certificate, Annex IV.4
Applicant organization
Bio-Rad
3 bd Raymond Poincaré
Marnes La Coquette,
92430
France
Pathogen
HIV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
72329
Test kit package size
20
Test Package Size
72329 Kit:
Device (20 units), Buffer Dropper (1 x 5 ml) and Microtubes 15 μl (1 x 20)
per kit
Device (20 units), Buffer Dropper (1 x 5 ml) and Microtubes 15 μl (1 x 20)
per kit
Identification name
72460
Test kit package size
20
Test Package Size
72329 Kit:
Device (20 units), Buffer Dropper (1 x 5 ml) and Microtubes 15 μl (1 x 20)
per kit
Device (20 units), Buffer Dropper (1 x 5 ml) and Microtubes 15 μl (1 x 20)
per kit
IVD Manufacturing Site(s)
Biokit S.A.
Can Malé s/n
Llicà d'Amunt,
8186
Spain
BioRad - Steenvoorde
Route de Cassel
Steenvoorde,
59114
France
Bio-Rad
3 bd Raymond Poincaré
Marnes La Coquette,
92430
France