- Device
- cobas HCV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150015
- Supplement
- S043
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2021-06-02
- Decision code
- APPR
- Date received
- 2021-05-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an update to the hazard information on the product labeling for kits on the cobas 6800/8800 Systems.