BIO-RAD MONOLISA ANTI-HBS EIA
FDA premarket approval P050048/S009 · decided 2013-12-12
Approval details
- PMA number
- P050048
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIO-RAD MONOLISA ANTI-HBS EIA
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Bio-Rad Laboratories
- Date received
- 2013-11-13
- Decision date
- 2013-12-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- CHANGE TO ADD TEST SAMPLES AS AN ADDITIONAL ACCEPTANCE CRITERION TO THE FINAL KIT RELEASE QUALITY CONTROL TESTING PROCEDURE.
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