PMA P000012S023

Device: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S023
Product code: MZP
Decision date: 2010-03-08
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: ELIMINATION OF FUNCTIONAL TESTING AT THE INCOMING RAW MATERIAL STAGE FOR A KIT COMPONENT USED IN THE DEVICE.

Current openFDA PMA Record

Device: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S023
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2010-03-08
Decision code: OK30
Date received: 2010-02-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ELIMINATION OF FUNCTIONAL TESTING AT THE INCOMING RAW MATERIAL STAGE FOR A KIT COMPONENT USED IN THE DEVICE.