SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0202-073-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
INNO-Lia HCV Score
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
80538
Test kit package size
20
Test Package Size
Test strips: 20 tests strips
Sample Diluent: 1 bottle of 30 mL
Ready-to-use Conjugate: 1 bottle of 45 mL
Negative Control: 1 bottle of 0
Sample Diluent: 1 bottle of 30 mL
Ready-to-use Conjugate: 1 bottle of 45 mL
Negative Control: 1 bottle of 0
IVD Manufacturing Site(s)
Fujirebio Europe NV
Technologiepark 6
Zwijnaarde,
9052
Belgium