SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0236-078-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Aptima HIV-1 Quant Dx Assay
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
Hologic, Inc.
10210 Genetic Center Drive
San Diego,
92121
United States of America
Pathogen
HIV
Specimen Type
Plasma
Serum
Product Code
Identification name
303014
Identification name
303095
Identification name
PRD-03000
Identification name
PRD-03001
Identification name
PRD-03002
Identification name
PRD-03003
IVD Manufacturing Site(s)
Hologic, Inc - GCD2
6333 Sequence Drive
San Diego,
92127
United States of America
Hologic, Inc - Willow Drive
10808 Willow Court
San Diego,
92127
United States of America
Hologic, Inc.
10210 Genetic Center Drive
San Diego,
92121
United States of America