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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.
 
DeviceBIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
Generic Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
Applicant
DIASORIN
1951 northwestern avenue
stillwater, MN 55082-0285
PMA NumberP970055
Supplement NumberS010
Date Received06/24/2011
Decision Date09/05/2012
Product Code
MYM[ Registered Establishments with MYM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at biotrin international ltd in dublin, ireland.
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