PMA P050028S092
- Device
- COBAS® AmpliPrep®, COBAS® TaqMan® HBV Test, v2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P050028
- Supplement
- S092
- Product code
- MKT
- Decision date
- 2024-02-23
- Classification
- Microbiology
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- to add a filling line
Current openFDA PMA Record#
- Device
- COBAS® AmpliPrep®, COBAS® TaqMan® HBV Test, v2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P050028
- Supplement
- S092
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2024-02-23
- Decision code
- OK30
- Date received
- 2024-02-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add a filling line