PMA P060031S003

Device: BIO-RAD MONOLISA ANTI-HBC EIA
Applicant: Bio-Rad Laboratories, Inc.
PMA number: P060031
Supplement: S003
Product code: LOM
Decision date: 2010-12-30
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order 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 OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. THE MONOLISA ANTI-HBC EIA IS INTENDED FOR MANUAL USE AND WITH THE BIO-RAD EVOLIS AUTOMATED MICROPLATE SYSTEM IN THE DETECTION OF TOTAL ANTIBODIES TO HEPATITIS B VIRUS.

Current openFDA PMA Record#

Device: BIO-RAD MONOLISA ANTI-HBC EIA
Applicant: Bio-Rad Laboratories, Inc.
PMA number: P060031
Supplement: S003
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2010-12-30
Decision code: APPR
Date received: 2009-09-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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 OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. THE MONOLISA ANTI-HBC EIA IS INTENDED FOR MANUAL USE AND WITH THE BIO-RAD EVOLIS AUTOMATED MICROPLATE SYSTEM IN THE DETECTION OF TOTAL ANTIBODIES TO HEPATITIS B VIRUS.