SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0461-027-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Alinity m HCV
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HCV NAT
Regulatory Version Submitted To PQ
Directive 98/79/EC: Product design examination certificate, Annex IV.4
Applicant organization
Abbott Molecular Inc.
1300 East Touhy Avenue
Des Plaines,
60018
United States of America
Pathogen
HCV
Specimen Type
Plasma
Serum
Product Code
Identification name
08N50-080
Test Package Size
192 tests/kit AMP kit (08N50-090)
12 tubes each neg, low pos, high pos ctrl (08N50-080)
4 tubes each calibrators A and B (08N50-070)
12 tubes each neg, low pos, high pos ctrl (08N50-080)
4 tubes each calibrators A and B (08N50-070)
Identification name
08N50-090
Test Package Size
192 tests/kit AMP kit (08N50-090)
12 tubes each neg, low pos, high pos ctrl (08N50-080)
4 tubes each calibrators A and B (08N50-070)
12 tubes each neg, low pos, high pos ctrl (08N50-080)
4 tubes each calibrators A and B (08N50-070)
Identification name
08N50-70
Test Package Size
192 tests/kit AMP kit (08N50-090)
12 tubes each neg, low pos, high pos ctrl (08N50-080)
4 tubes each calibrators A and B (08N50-070)
12 tubes each neg, low pos, high pos ctrl (08N50-080)
4 tubes each calibrators A and B (08N50-070)
IVD Manufacturing Site(s)
Abbott Molecular Inc.
1300 East Touhy Avenue
Des Plaines,
60018
United States of America