- Device
- Cobas HCV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150015
- Supplement
- S032
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2019-12-11
- Decision code
- APPR
- Date received
- 2019-07-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in material used to manufacture a critical instrument component.