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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
Trade NameELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP100032
Date Received07/30/2010
Decision Date06/27/2011
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 11M-0503
Notice Date 07/01/2011
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
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