PMA P150014S041
- Device
- cobas HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S041
- Product code
- MKT
- Decision date
- 2021-06-02
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Approval for an update to the hazard information on the product labeling for kits on the cobas 6800/8800 Systems.
Current openFDA PMA Record#
- Device
- cobas HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S041
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- 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.