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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 NameBIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igg
Generic Namebiotrin parvovirus b19 igg eia
ApplicantBIOTRIN TECHNOLOGIES
PMA NumberP970054
Supplement NumberS001
Date Received11/15/2002
Decision Date01/09/2003
Product Code
MYL[ Registered Establishments with MYL ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding a quality assurance inspection step.
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