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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igg
Generic Nameassay,enzyme linked immunosorbent,parvovirus b19 igg
Applicant
DIASORIN
1951 northwestern avenue
stillwater, MN 55082-0285
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/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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