SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0153-031-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Genie Fast HIV 1/2
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 (venous)
Product Code
Identification name
72327
Test kit package size
25
Test Package Size
Kits contain: 25 Test cassettes, 5 mL x 1 Bottle Diluent, 50 x Disposable transfer pipettes
Identification name
72330
Test kit package size
50
Test Package Size
Kits contain 50 x Test cassettes, 5 mL x 1 bottle of Diluent, and 50 x Disposable transfer pipettes
Identification name
72347
Test kit package size
25
Test Package Size
25 x Test cassettes, 5 mL x Disposable transfer pipettes, 25 x Microsafes (80μl), 25 x lancets, and 25 x alcoopads
IVD Manufacturing Site(s)
BioRad - Steenvoorde
Route de Cassel
Steenvoorde,
59114
France
BioRad - Steenvoorde
Route de Cassel
Steenvoorde,
59114
France
Bio-Rad
3 bd Raymond Poincaré
Marnes La Coquette,
92430
France