BIO-RAD MONOLISA ANTI-HBC EIA
FDA premarket approval P060031 · decided 2007-04-27
Approval details
- PMA number
- P060031
- Trade name
- BIO-RAD MONOLISA ANTI-HBC EIA
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Bio-Rad Laboratories, Inc.
- Date received
- 2006-10-30
- Decision date
- 2007-04-27
- Days to decision
- 179 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- APPROVAL FOR THE BIO-RAD MONOLISA ANTI-HBC EIA. THE DEVICE 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 OTHER HBV SEROLOGICAL MARKETS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTI
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