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Device | Parvovirus B19 IgG Enzyme Immunoassay |
Generic Name | ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG |
Applicant | DIASORIN 1951 NORTHWESTERN AVENUE STILLWATER, MN 55082-0285 |
PMA Number | P970054 |
Supplement Number | S018 |
Date Received | 03/30/2020 |
Decision Date | 04/21/2020 |
Product Code |
MYL |
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 Replace a critical raw material (and its supplier) used in the shipment of manufactured kits. |