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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 IGM ENZYME IMMUNOASSAY
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
ApplicantBIOTRIN TECHNOLOGIES
PMA NumberP970055
Supplement NumberS001
Date Received11/15/2002
Decision Date01/09/2003
Product Code
MYM[ Registered Establishments with MYM ]
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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