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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode MYL PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
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PMA
Number
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Decision
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ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. P150045 09/19/2017
Parvovirus B19 IgG Enzyme Immunoassay DIASORIN P970054 S013 03/09/2017
PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (V5191GUS) DIASORIN P970054 S012 01/19/2017
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