PMA P000012S028
- Device
- Cobas Ampliprep/cobas Amplicor Hcv Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S028
- Decision date
- 2010-12-10
Current openFDA PMA Record
- Device
- COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S028
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2010-12-10
- Decision code
- OK30
- Date received
- 2010-09-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO REPLACE THE AMPLICON INACTIVATION TEST THAT IS CURRENTLY PERFORMED ON HCV MASTER MIXES (MMX) DURING IN-PROCESS RELEASE TESTING WITH A RECOMBINANT ENZYME URACIL-N-GLYCOSYLASE (RUNG) ACTIVITY TEST.