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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.
 
DeviceBIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM IN VITRO DIAGNOSTIC DEVICE
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
Generic Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
Applicant
DIASORIN
1951 northwestern avenue
stillwater, MN 55082-0285
PMA NumberP970055
Supplement NumberS008
Date Received02/17/2010
Decision Date03/19/2010
Product Code
MYM
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New production procedure to prepare a viral master stock, and the documentation of the tubing priming steps for the plate coating equipment used in the device.
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