SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0640-027-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Alinity m HIV-1
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HIV 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
HIV
Specimen Type
Plasma
Serum
Product Code
Identification name
08N45-090
Test Package Size
08N45-090 - storage conditions above only for this kit component - Plasma provides quantitative results, serum is used for qualitative confirmatory result only