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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameELECSYS ANTI-HBS (ANTI-HBS) TEST SYSTEM
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameimmunoassay for antibody t hepatitis b surface antigen; anti-hbs control reagents
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP010054
Supplement NumberS017
Date Received10/11/2011
Decision Date04/23/2012
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the extension of the elecsys anti-hbs test system onto the cobas e 602 immunoassay analyzer. The device, as modified, will be marketed under the trade elecsys anti-hbs test system and is indicated for: elecsys anti-hbs immunoassay - immunoassay for the in vitro quantitative determination of total antibodies to the hepatitis b surface antigen (hbsag) in human serum and plasma (edta). The electrochemiluminescence immunoassay "eclia" is intended for use on the roche elecsys 2010, modular analytics e170 (elecsys module), cobas e 411, cobas e 601, and cobas e 602 immunoassay analyzers. Assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following hbv vaccination, or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The detection of anti-hbs is indicative of laboratory diagnosis of seroconversion from hepatitis b virus (hbv) infection.
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