| 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 IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER |
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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 | P100032 |
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| Date Received | 07/30/2010 |
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| Decision Date | 06/27/2011 |
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| Product Code | |
| Docket Number | 11M-0503 |
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| Notice Date | 07/01/2011 |
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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 immunoassay & elecsys precicontrol anti-hbc for use on the elecsys 2010 immunoassay analyzer. This device is indicated for the in vitro qualitative determination of total antibodies to hepatitis b core antigen (anti-hbc) in human serum and plasma (lithium-heparin, sodium-citrate, k2-edta) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis b (hbv) infection. The detection of total anti-hbc is indicative of a laboratory diagnosis for hbv infection. Further hbv serological marker testing is required to define the specific disease state. The elecsys anti-hbc immunoassay's performance has not been established for the monitoring of hbv disease or therapy. The electrochemilumi-nescence immunoassay eclia is intended for use on the elecsys 2010 immunoassay analyzer. The elecsys precicontrol anti-hbc is used for quality control of the elecsys anti-hbc immunoassay on the elecsys 2010 immunoassay analyzer. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S002 S003 S004 S005 S006
S008 |
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