SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0229-031-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Monolisa HCV Ag-Ab ULTRA V2
Assay Type
IA - Enzyme immunoassay EIA
IVD Public Report Category
HCV 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
HCV
Specimen Type
Plasma
Serum
Product Code
Identification name
72561
Test kit package size
96
Identification name
72562
Test kit package size
480
IVD Manufacturing Site(s)
Bio-Rad
3 bd Raymond Poincaré
Marnes La Coquette,
92430
France
BioRad - Steenvoorde
Route de Cassel
Steenvoorde,
59114
France