MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT
FDA premarket approval P050048/S005 · decided 2010-11-23
Approval details
- PMA number
- P050048
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Bio-Rad Laboratories
- Date received
- 2010-06-17
- Decision date
- 2010-11-23
- Days to decision
- 159 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIO-RAD LABORATORIES IN WOODINVILLE, WASHINGTON.
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