PMA P000012S025
- Device
- Cobas Ampliprep/cobas Amplicor Hvc Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S025
- Decision date
- 2010-09-23
Current openFDA PMA Record
- Device
- COBAS AMPLIPREP/COBAS AMPLICOR HVC TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S025
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2010-09-23
- Decision code
- OK30
- Date received
- 2010-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO REDUCE THE BATCH SIZE FOR MANUFACTURE OF SUBSTRATE A, SUBATRATE B, STOP REAGENT AND WASH CONCENTRATE BULK SOLUTION.