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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 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 NumberS011
Date Received12/22/2009
Decision Date01/07/2010
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the extension of the anti-hbs calcheck shelf-life from nine months to fourteen months when stored at 2-8 degrees c.
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