PMA P000012S047

Device: COBAS AMPLICOR HCV TEST V2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S047
Product code: MZP
Decision date: 2014-01-09
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: CHANGE TO DISCONTINUE CHEMICAL TESTING FOR POTASSIUM CONCENTRATION IN MASTERMIXES.

Current openFDA PMA Record

Device: COBAS AMPLICOR HCV TEST V2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S047
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2014-01-09
Decision code: OK30
Date received: 2013-12-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO DISCONTINUE CHEMICAL TESTING FOR POTASSIUM CONCENTRATION IN MASTERMIXES.