PMA P050048S009
- Device
- BIO-RAD MONOLISA ANTI-HBS EIA
- Applicant
- Bio-Rad Laboratories
- PMA number
- P050048
- Supplement
- S009
- Product code
- LOM
- Decision date
- 2013-12-12
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- CHANGE TO ADD TEST SAMPLES AS AN ADDITIONAL ACCEPTANCE CRITERION TO THE FINAL KIT RELEASE QUALITY CONTROL TESTING PROCEDURE.
Current openFDA PMA Record#
- Device
- BIO-RAD MONOLISA ANTI-HBS EIA
- Applicant
- Bio-Rad Laboratories
- PMA number
- P050048
- Supplement
- S009
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2013-12-12
- Decision code
- OK30
- Date received
- 2013-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO ADD TEST SAMPLES AS AN ADDITIONAL ACCEPTANCE CRITERION TO THE FINAL KIT RELEASE QUALITY CONTROL TESTING PROCEDURE.