PMA P000012S027
- Device
- Cobas Amplicor Hcv Test/cobas Ampliprep/cobas Ampl
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S027
- Decision date
- 2011-06-27
Current openFDA PMA Record
- Device
- COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S027
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2011-06-27
- Decision code
- APPR
- Date received
- 2010-09-14
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE TEST METHODS 1) MAGNETIC SUSCEPTIBILITY; AND 2) SURFACE AREA OF THE TOSYLATED MAGNETIC BEADS USED BY THE VENDOR.