| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM |
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| Classification Name | test, hepatitis b (b core, be antigen, be antibody, b core igm) |
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| Applicant | ROCHE DIAGNOSTICS CORP. |
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| PMA Number | P110022 |
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| Date Received | 05/09/2011 |
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| Decision Date | 10/26/2011 |
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| Product Code | |
| Docket Number | 11M-0786 |
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| Notice Date | 11/04/2011 |
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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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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the elecsys anti-hbc igm immunoassay and elecsys precicontrol anti-hbc igm for use on the cobas e 601 immunoassay analyzer. This device is indicated for: the elecsys anti-hbc igm immunoassay is intended for the in vitro qualitative determination of igm antibodies to hepatitis b core antigen (anti-hbc igm) in human serum or plasma (potassium edta, lithium heparin. Sodium heparin, sodium citrate) in adult patients with symptoms of hepatitis or who may be at risk for hepatitis b (1ibv) injection. The presence of anti-hbc igm. In conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis b virus (hbv) infection. The elecsys anti-hbc igm immunoassay's performance has not been established for the monitoring of hbv disease or therapy. The electrochemilu-minescence immunoassay "eclia" is intended for use on the cobas e 601 immunoassay analyzer. Precicontroi anti-hbc igm elecsys precicontrol anti-hbc igm is used for quality control of the elecsys anti-hbc igm immunoassay on the cobas e 601 immunoassay analyzer. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S002 S003 S004 S005 S006
S009 |
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