PMA P050048
- Device
- MONOLISA ANTI-HBS EIA
- Applicant
- Bio-Rad Laboratories
- PMA number
- P050048
- Supplement
- S009
- Product code
- LOM
- Decision date
- 2025-04-18
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- a Validation to test the equivalency of a component with another so the original material can be replaced
Current openFDA PMA Record#
- Device
- MONOLISA ANTI-HBS EIA
- Applicant
- Bio-Rad Laboratories
- PMA number
- P050048
- Supplement
- S010
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2025-04-18
- Decision code
- OK30
- Date received
- 2025-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a Validation to test the equivalency of a component with another so the original material can be replaced