PMA P150014S049
- Device
- cobas® HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S049
- Product code
- MKT
- Decision date
- 2024-01-18
- Classification
- Microbiology
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- a scale-up of a bulk manufacturing process
Current openFDA PMA Record#
- Device
- cobas® HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S049
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2024-01-18
- Decision code
- OK30
- Date received
- 2023-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a scale-up of a bulk manufacturing process