PMA P000010S024

Device: AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000010
Supplement: S024
Product code: MZP
Decision date: 2012-01-11
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: APPROVAL FOR A CHANGE TO THE TEST METHOD FOR DETERMINATION OF DITHIOTHREITOL IN BULK AND VIALED LYSIS REAGENTS.

Current openFDA PMA Record

Device: AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000010
Supplement: S024
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2012-01-11
Decision code: APPR
Date received: 2011-07-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO THE TEST METHOD FOR DETERMINATION OF DITHIOTHREITOL IN BULK AND VIALED LYSIS REAGENTS.