PMA P150014S039
- Device
- cobas HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S039
- Product code
- MKT
- Decision date
- 2020-10-07
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Approval for changes being effected to update hazard labeling.
Current openFDA PMA Record#
- Device
- cobas HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S039
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2020-10-07
- Decision code
- APPR
- Date received
- 2020-09-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes being effected to update hazard labeling.