BIO RAD MONOLISA ANTI-HBC IGM EIA
FDA premarket approval P060034 · decided 2007-05-31
Approval details
- PMA number
- P060034
- Trade name
- BIO RAD MONOLISA ANTI-HBC IGM EIA
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Bio-Rad Laboratories, Inc.
- Date received
- 2006-11-22
- Decision date
- 2007-05-31
- Days to decision
- 190 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 IGM EIA. THE DEVICE IS INDICATED FOR: THE BIO-RAD MONOLISA ANTI-HBC IGM EIA IS AN ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETECTION OF IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, SODIUM CITRATE, ACD [ACID CITRATE DEXTROSE], LITHIUM HEPARIN AND SODIUM HEPARIN). ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV
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