| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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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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| Date Received | 10/30/2006 |
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| Decision Date | 04/27/2007 |
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| Product Code |
LOM |
| Docket Number | 07M-0467 |
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| Notice Date | 12/04/2007 |
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| Advisory Committee |
Microbiology |
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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 THE BIO-RAD MONOLISA ANTI-HBC EIA. THE DEVICE 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 MARKETS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 |
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