SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0096-031-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Genscreen ULTRA HIV Ag-Ab
Assay Type
IA - Enzyme immunoassay EIA
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
Product Code
Identification name
72386
Test Package Size
The test kit is marketed the following different configurations:
1
1
Identification name
72388
Test Package Size
The test kit is marketed the following different configurations:
1
1
IVD Manufacturing Site(s)
BioRad - Steenvoorde
Route de Cassel
Steenvoorde,
59114
France
Bio-Rad
3 bd Raymond Poincaré
Marnes La Coquette,
92430
France