PMA P000012S039

Device: COBAS AMPLICOR HCV TEST, V2.0, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S039
Product code: MZP
Decision date: 2012-09-14
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: CHANGE TO ADJUST THE ENVIRONMENTAL TESTING PERFORMED AT THE RMS BRANCHBURG FACILITY.

Current openFDA PMA Record

Device: COBAS AMPLICOR HCV TEST, V2.0, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S039
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2012-09-14
Decision code: OK30
Date received: 2012-08-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO ADJUST THE ENVIRONMENTAL TESTING PERFORMED AT THE RMS BRANCHBURG FACILITY.