| 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 IGM 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 | P060034 |
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| Date Received | 11/22/2006 |
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| Decision Date | 05/31/2007 |
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| Product Code |
LOM |
| Docket Number | 07M-0254 |
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| Notice Date | 06/28/2007 |
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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 IGM EIA. THE DEVICE IS INDICATED FOR: THE BIO-RAD MONOLISA ANTI-HBC IGM EIA IS AN ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETECTION OF IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR 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. |
| 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 S004 S005 S006 S007 S008 |
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