SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0147-046-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
COBAS AmpliPrep / COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 96)
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 Molecular Systems, Inc.
4300 Hacienda Drive, CA
Branchburg Township,
8876
United States of America
Pathogen
HIV
Specimen Type
Plasma
Product Code
Identification name
028127387001
Identification name
03051315001
Identification name
03121453001
Identification name
03587797190
Identification name
07347308001
Identification name
05212294190
Identification name
05527503001
Identification name
05807875001
IVD Manufacturing Site(s)
Roche Diagnostics GmbH
Nonnenwald 2
Penzberg,
82377
Germany
Roche Molecular Systems, Inc.
1080 US Hwy 202 South
Branchburg Township,
8876
United States of America