SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0201-073-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
INNOTEST HCV Ab IV
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
Fujirebio Europe NV
Technologiepark 6
Zwijnaarde,
9052
Belgium
Pathogen
HCV
Specimen Type
Plasma
Serum
Product Code
Identification name
80068
Test kit package size
192
Test Package Size
Kit contains (80068 or 80330):
- 1 vial containing 1
- 1 vial containing 1
Identification name
80330
Test kit package size
480
Test Package Size
Kit contains (80068 or 80330):
- 1 vial containing 1
- 1 vial containing 1
IVD Manufacturing Site(s)
Fujirebio Europe NV
Technologiepark 6
Zwijnaarde,
9052
Belgium