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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 INTERNATIONALS PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igg
Generic Namebiotrin parvovirus b19 igg eia
ApplicantBIOTRIN INTERNATIONAL, LTD.
PMA NumberP970054
Supplement NumberS007
Date Received02/09/2009
Decision Date03/03/2009
Product Code
MYL[ Registered Establishments with MYL ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Removal of day 7 drop off testing and related specification.
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