| 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 EIA |
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| Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
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| Applicant | Bio-Rad Laboratories, Inc.
6565 185TH AVE., N.E.
REDMOND, WA 98052 |
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| PMA Number | P060031 |
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| Supplement Number | S003 |
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| Date Received | 09/28/2009 |
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| Decision Date | 12/30/2010 |
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| Product Code |
LOM |
| Advisory Committee |
Microbiology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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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. |
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