PMA P000012S049

Device: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S049
Product code: MZP
Decision date: 2014-04-28
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: ADDITION OF A NEW SUPPLIER FOR SUBASSEMBLIES IN THE MANUFACTURE OF THE COBAS AMPLIPREP INSTRUMENT.

Current openFDA PMA Record

Device: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S049
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2014-04-28
Decision code: OK30
Date received: 2014-03-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A NEW SUPPLIER FOR SUBASSEMBLIES IN THE MANUFACTURE OF THE COBAS AMPLIPREP INSTRUMENT.