Bio Rad Monolisa Anti-Hbc Igm Eia
FDA premarket approval P060034 · Qualitative and Quantitative Hepatitis B Virus Antibody assays
PMA numberP060034
Approval
- Applicant
- Bio-Rad Laboratories, Inc.
- Received
- November 22, 2006
- Decision date
- May 31, 2007 (APRL)
- Supplements
- 7, latest March 19, 2014
- Product code
- SEI – Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Approval order 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 INFECTION.