- Device
- BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT
- Applicant
- Bio-Rad Laboratories
- PMA number
- P050048
- Supplement
- S007
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2012-11-13
- Decision code
- APPR
- Date received
- 2012-02-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE MODIFICATION OF THE QUALITY CONTROL TESTING SPECIFICATION FOR THE 400 MIU/ML CALIBRATOR IN THE DEVICE.