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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.
 
DeviceBIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igg
Generic Nameassay,enzyme linked immunosorbent,parvovirus b19 igg
Applicant
DIASORIN
1951 northwestern avenue
stillwater, MN 55082-0285
PMA NumberP970054
Supplement NumberS001
Date Received11/15/2002
Decision Date01/09/2003
Product Code
MYL[ Registered Establishments with MYL ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDING A QUALITY ASSURANCE INSPECTION STEP.
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