Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | BIO-RAD MONOLISA ANTI-HBC IGM EIA |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Bio-Rad Laboratories, Inc. 6565 185TH AVE., N.E. REDMOND, WA 98052 |
PMA Number | P060034 |
Supplement Number | S004 |
Date Received | 09/25/2009 |
Decision Date | 08/02/2010 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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