PMA P000012S045

Device: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S045
Product code: MZP
Decision date: 2013-10-09
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: CHANGE FOR THE ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE INSTRUMENT FOR THE DEVICES.

Current openFDA PMA Record

Device: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S045
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2013-10-09
Decision code: OK30
Date received: 2013-09-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE FOR THE ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE INSTRUMENT FOR THE DEVICES.