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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 IN VITRO DIAGNOSTIC DEVICE
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
ApplicantBIOTRIN INTERNATIONAL, LTD.
PMA NumberP970055
Supplement NumberS008
Date Received02/17/2010
Decision Date03/19/2010
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 
New production procedure to prepare a viral master stock, and the documentation of the tubing priming steps for the plate coating equipment used in the device.
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