PMA P150014S056
- Device
- cobas® HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S056
- Product code
- MKT
- Decision date
- 2025-10-17
- Classification
- Microbiology
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Approval for cobas HBV on the upgraded cobas 6800/8800 Systems 2.0
Current openFDA PMA Record#
- Device
- cobas® HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S056
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2025-10-17
- Decision code
- APPR
- Date received
- 2025-07-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for cobas HBV on the upgraded cobas 6800/8800 Systems 2.0