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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.
 
DeviceBIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
Generic NameASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
ApplicantDiasorin
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP970055
Supplement NumberS011
Date Received07/06/2011
Decision Date08/03/2011
Product Code MYM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MANUFACTURING PROCESS CHANGE FOR PREPARATION OF THE SENSITIVITY STANDARDS, USED AS A REFERENCE MATERIAL TO ESTABLISH THE CUT-OFF VALUE FOR THE DEVICE.
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