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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 IGG ENZYME IMMUNOASSAY
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igg
Generic Namebiotrin parvovirus b19 igg eia
ApplicantDIASORIN
PMA NumberP970054
Supplement NumberS009
Date Received06/24/2011
Decision Date09/05/2012
Product Code
MYL[ Registered Establishments with MYL ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
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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