BIO-RAD MONOLISA ANTI-HBC EIA
FDA premarket approval P060031/S002 · decided 2009-02-25
Approval details
- PMA number
- P060031
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BIO-RAD MONOLISA ANTI-HBC EIA
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Bio-Rad Laboratories, Inc.
- Date received
- 2009-02-12
- Decision date
- 2009-02-25
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- APPROVAL FOR CHANGES IN THE RECOMMENDATION FOR SPECIMEN STORAGE.
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