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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.
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
Generic Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
1951 northwestern avenue
stillwater, MN 55082-0285
PMA NumberP970055
Supplement NumberS002
Date Received03/23/2005
Decision Date04/01/2005
Product Code
MYM[ Registered Establishments with MYM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No