BIO-RAD MONOLISA ANTI-HBC EIA
FDA premarket approval P060031/S003 · decided 2010-12-30
Approval details
- PMA number
- P060031
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2009-09-28
- Decision date
- 2010-12-30
- Days to decision
- 458 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- APPROVAL FOR USE ON THE EVOLIS AUTOMATED MICROPLATE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIO-RAD MONOLISA ANTI-HBC EIA AND IS INDICATED FOR: THE MONOLISA ANTI-HBC EIA IS AN ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES (IGG/IGM) TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, SODIUM CITRATE, ACD (ACID CITRATE DEXTROSE), LITHIUM HEPARIN AND SODIUM HEPARIN). ASSAY RESULTS MAY BE USED WITH OTH
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