PMA P000012S026
- Device
- Cobas Ampliprep/cobas Amplicor Hcv Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S026
- Decision date
- 2011-05-24
Current openFDA PMA Record
- Device
- COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S026
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2011-05-24
- Decision code
- APPR
- Date received
- 2010-08-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ELIMINATING AURINTRICARBOXYLIC ACID (ATA) ACTIVITY TESTING IN COBAS AMPLIPREP/ COBAS AMPLICOR HCV INTERNAL CONTROL BUFFER AND SPECIMEN DILUENT BULK SOLUTIONS.