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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 NameBIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
ApplicantBIOTRIN INTERNATIONAL, LTD.
PMA NumberP970055
Supplement NumberS011
Date Received07/06/2011
Decision Date08/03/2011
Product Code
MYM[ Registered Establishments with MYM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing process change for preparation of the sensitivity standards, used as a reference material to establish the cut-off value for the device.
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