SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0203-073-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
INNO-Lia HIV I/II Score
Assay Type
IA (immunoassay)
IVD Public Report Category
HIV 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
HIV
Specimen Type
Plasma
Serum
Product Code
Identification name
80540
Test Package Size
The test kit contains:
- Antigen-coated test strips (20 x strips), reference 57330
- Sample diluent (1 x30ml/vial), reference 57304
- Negative control (1 x 0
- Antigen-coated test strips (20 x strips), reference 57330
- Sample diluent (1 x30ml/vial), reference 57304
- Negative control (1 x 0
IVD Manufacturing Site(s)
Fujirebio Europe NV
Technologiepark 6
Zwijnaarde,
9052
Belgium