PMA P000012S040

Device: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S040
Product code: MZP
Decision date: 2012-10-10
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: SCALE UP OF A BULK ENZYME USED IN THE MANUFACTURE OF KIT COMPONENTS.

Current openFDA PMA Record

Device: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S040
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2012-10-10
Decision code: OK30
Date received: 2012-09-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: SCALE UP OF A BULK ENZYME USED IN THE MANUFACTURE OF KIT COMPONENTS.