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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 AND HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS
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 NumberS004
Date Received06/13/2006
Decision Date06/30/2006
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the standardization process for the elecsys anti-hbs immunoassay and elecsys precicontrol anti-hbs assay for use on the elecsys 2010 analyzer. The device, as modified, will be marketed under the trade name elecsys anti-hbs immunoassay and elecsys precicontrol anti-hbs and is indicated for the qualitative detection in human serum and plasma.
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