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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.
 
DevicePARVOVIRUS 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 NumberS005
Date Received06/01/2007
Decision Date10/10/2007
Product Code
MYM[ Registered Establishments with MYM ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE REDUCTION IN PLATE WASH VOLUME.
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