BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT
FDA premarket approval P050048/S007 · decided 2012-11-13
Approval details
- PMA number
- P050048
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIO-RAD 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
- 2012-02-22
- Decision date
- 2012-11-13
- Days to decision
- 265 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- APPROVAL FOR THE MODIFICATION OF THE QUALITY CONTROL TESTING SPECIFICATION FOR THE 400 MIU/ML CALIBRATOR IN THE DEVICE.
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