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. |
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Device | PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY |
Generic Name | ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM |
Applicant | DIASORIN 1951 NORTHWESTERN AVENUE STILLWATER, MN 55082-0285 |
PMA Number | P970055 |
Supplement Number | S009 |
Date Received | 05/14/2010 |
Decision Date | 06/10/2010 |
Product Code |
MYM |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement PROCEDURE CHANGE FOR A COMPONENT. |
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