SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0151-027-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Abbott RealTime HIV-1 Qualitative (Manual)
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
Whole blood (dried blood spot)
Product Code
Identification name
4N66-01
Identification name
4N66-66
Identification name
4N66-80
Identification name
4N66-90
Identification name
6K12-24
Identification name
9K15-01
IVD Manufacturing Site(s)
Abbott Molecular Inc.
1300 East Touhy Avenue
Des Plaines,
60018
United States of America