PMA P000012S054
- Device
- Cobas Amplicor Hcv Test Version 2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S054
- Decision date
- 2015-10-15
Current openFDA PMA Record
- Device
- COBAS AMPLICOR HCV TEST VERSION 2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S054
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2015-10-15
- Decision code
- OK30
- Date received
- 2015-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATION OF AN IN-PROCESS FUNCTIONAL TEST FOR A FINAL COMPONENT.