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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 NamePARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igg
Generic Namebiotrin parvovirus b19 igg eia
ApplicantBIOTRIN TECHNOLOGIES
PMA NumberP970054
Supplement NumberS006
Date Received07/31/2007
Decision Date08/24/2007
Product Code
MYL[ Registered Establishments with MYL ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in packaging material.
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