SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0221-118-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48)
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
Roche Diagnostics GmbH
Sandhofer Strasse 116
Penzberg,
82377
Germany
Pathogen
HIV
Specimen Type
Plasma
Whole blood (dried blood spot)
Product Code
Identification name
28127387001
Identification name
3051315001
Identification name
3279332001
Identification name
3516440001
Identification name
3587797190
Identification name
5807875001
Identification name
6693083190
Identification name
6989861190
IVD Manufacturing Site(s)
Roche Molecular Systems, Inc.
1080 US Hwy 202 South
Branchburg Township,
8876
United States of America
Roche Diagnostics GmbH
Nonnenwald 2
Penzberg,
82377
Germany