SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0365-046-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
cobas HIV-1 Quantitative nucleic acid test for use on the cobas 5800/6800/8800 Systems
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
Plasma (dried plasma spot)
Plasma (plasma separator device)
Product Code
Identification name
09040803190
Test kit package size
192
Test Package Size
192T Kit size
Identification name
07000995190
Test kit package size
96
Test Package Size
96T kit size
IVD Manufacturing Site(s)
Roche Diagnostics GmbH
Nonnenwald 2
Penzberg,
82377
Germany