SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0465-118-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
cobas HCV (Quantitative nucleic acid test for use on the cobas 6800/8800 Systems)
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HCV 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
HCV
Specimen Type
Plasma
Serum
Product Code
Identification name
6997732190
Test kit package size
96
Test Package Size
Cassette containing:
Proteinase Solution (PASE)
RNA Quantitation Standard (RNA-QS)
Elution Buffer (EB)
Master Mix REagent 1 (MMX-R1)
HCV Master Mix Reagent 2 (HCV MMX-R2)
Proteinase Solution (PASE)
RNA Quantitation Standard (RNA-QS)
Elution Buffer (EB)
Master Mix REagent 1 (MMX-R1)
HCV Master Mix Reagent 2 (HCV MMX-R2)