PMA P060034S004

Device: BIO-RAD MONOLISA ANTI-HBC IGM EIA
Applicant: Bio-Rad Laboratories, Inc.
PMA number: P060034
Supplement: S004
Product code: LOM
Decision date: 2010-08-02
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR EXPANDING THE INTENDED USE TO INCLUDE USE WITH THE EVOLISAUTOMATED MICROPLATE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMEMONOLISA ANTI-HBC IGM EIA AND IS INDICATED FOR USE IN THE QUALITATIVE DETECTION OF IGMANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUMEDTA, 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 IGM IS INTENDED FORMANUAL USE AND WITH THE BIO-RAD EVOLIS AUTOMATED MICROPLATE SYSTEM IN THE DETECTION OFIGM ANTIBODIES TO HEPATITIS B VIRUS.

Current openFDA PMA Record#

Device: BIO-RAD MONOLISA ANTI-HBC IGM EIA
Applicant: Bio-Rad Laboratories, Inc.
PMA number: P060034
Supplement: S004
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2010-08-02
Decision code: APPR
Date received: 2009-09-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR EXPANDING THE INTENDED USE TO INCLUDE USE WITH THE EVOLISAUTOMATED MICROPLATE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMEMONOLISA ANTI-HBC IGM EIA AND IS INDICATED FOR USE IN THE QUALITATIVE DETECTION OF IGMANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUMEDTA, 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 IGM IS INTENDED FORMANUAL USE AND WITH THE BIO-RAD EVOLIS AUTOMATED MICROPLATE SYSTEM IN THE DETECTION OFIGM ANTIBODIES TO HEPATITIS B VIRUS.