SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0710-118-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
cobas HIV-1 Nucleic acid test for use on the cobas 4800 System
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
Plasma (plasma separator device)
Product Code
Identification name
08792992190
Test kit package size
120
Test Package Size
lysis kit 960t - 06979548190,
specimen pre-extraction reagent - 08064695190,
cobas 4800 system extraction (deepwell) plate 2
specimen pre-extraction reagent - 08064695190,
cobas 4800 system extraction (deepwell) plate 2