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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 CALCHECK
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 NumberS009
Date Received06/09/2008
Decision Date07/09/2008
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the introduction of the elecsys anti-hbs calcheck for use with the elecsys anti-hbs test system. The elecsys anti-hbs calcheck is used for the verification of the calibration established with the elecsys anti-hbs immunoassay on the elecsys 2010 and modular analytics e170 immunoassay analyzers. The elecsys anti-hbs calcheck is not a calibrator.
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