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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 IgG Enzyme Immunoassay
Generic NameASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
ApplicantDiasorin
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP970054
Supplement NumberS018
Date Received03/30/2020
Decision Date04/21/2020
Product Code MYL 
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  
Replace a critical raw material (and its supplier) used in the shipment of manufactured kits.
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