PMA P060031S002
- Device
- BIO-RAD MONOLISA ANTI-HBC EIA
- Applicant
- Bio-Rad Laboratories, Inc.
- PMA number
- P060031
- Supplement
- S002
- Product code
- LOM
- Decision date
- 2009-02-25
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL FOR CHANGES IN THE RECOMMENDATION FOR SPECIMEN STORAGE.
Current openFDA PMA Record#
- Device
- BIO-RAD MONOLISA ANTI-HBC EIA
- Applicant
- Bio-Rad Laboratories, Inc.
- PMA number
- P060031
- Supplement
- S002
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2009-02-25
- Decision code
- APPR
- Date received
- 2009-02-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES IN THE RECOMMENDATION FOR SPECIMEN STORAGE.