- Device
- cobas HCV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150015
- Supplement
- S039
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2020-11-02
- Decision code
- APPR
- Date received
- 2020-07-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- changes to the cobas HBV Assay Specific Analytical Package (ASAP) software for use with the cobas HBV test (P150014) and cobas HCV ASAP software for use with the cobas HCV test (P150015) for use with the cobas 6800/8800