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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.
 
DeviceParvovirus B19 IgM Enzyme Immunoassay
Generic NameASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
ApplicantDiasorin
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP970055
Supplement NumberS015
Date Received02/08/2017
Decision Date03/09/2017
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  
Addition of a variation test for materials used in the manufacture of kit reagents.
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