SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0126-046-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
COBAS AmpliPrep / COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 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 Molecular Systems, Inc.
4300 Hacienda Drive, CA
Branchburg Township,
8876
United States of America
Pathogen
HIV
Specimen Type
Plasma
Product Code
Identification name
3587797109
Identification name
5212294190
Test kit package size
48
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