SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0528-046-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
cobas HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas 6800/8800 Systems and cobas HIV-1/HIV-2 Qualitative 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
Serum
Whole blood (dried blood spot)
Product Code
Identification name
7862113190
Test kit package size
96
Test Package Size
PASE - proteinase solution
IC - internal control
EB - elution buffer
MMX-R1 - master mix reagent 1
HIV-1/HIV-2 master mix reagent 2 - HIV-1/HIV-2 MMX-R2
IC - internal control
EB - elution buffer
MMX-R1 - master mix reagent 1
HIV-1/HIV-2 master mix reagent 2 - HIV-1/HIV-2 MMX-R2
Identification name
09040528190
Test kit package size
192
Test Package Size
PASE - proteinase solution
IC - internal control
EB - elution buffer
MMX-R1 - master mix reagent 1
HIV-1/HIV-2 master mix reagent 2 - HIV-1/HIV-2 MMX-R2
IC - internal control
EB - elution buffer
MMX-R1 - master mix reagent 1
HIV-1/HIV-2 master mix reagent 2 - HIV-1/HIV-2 MMX-R2
IVD Manufacturing Site(s)
Roche Molecular Systems, Inc.
1080 US Hwy 202 South
Branchburg Township,
8876
United States of America