PMA P050048S006
- Device
- BIO-RAD MONOLISA ANTI -HBS EIA
- Applicant
- Bio-Rad Laboratories
- PMA number
- P050048
- Supplement
- S006
- Product code
- LOM
- Decision date
- 2010-09-27
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL FOR A CHANGE IN SUPPLIER FOR THE HEPATITIS B ANTIGENS USED IN THE MANUFACTURE OF THE DEVICE.
Current openFDA PMA Record#
- Device
- BIO-RAD MONOLISA ANTI -HBS EIA
- Applicant
- Bio-Rad Laboratories
- PMA number
- P050048
- Supplement
- S006
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2010-09-27
- Decision code
- APPR
- Date received
- 2010-06-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN SUPPLIER FOR THE HEPATITIS B ANTIGENS USED IN THE MANUFACTURE OF THE DEVICE.