- Device
- MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT
- Applicant
- Bio-Rad Laboratories
- PMA number
- P050048
- Supplement
- S005
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2010-11-23
- Decision code
- APPR
- Date received
- 2010-06-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIO-RAD LABORATORIES IN WOODINVILLE, WASHINGTON.