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FDA COVID-19 Update

Additional EUAs issued for serology tests to detect the presence of coronavirus antibodies

By: Contract Pharma

Contract Pharma Staff

The following are some of the U.S. FDA’s actions taken, as of April 15, in its ongoing response effort to the COVID-19 pandemic: The FDA issued two new emergency use authorizations (EUAs) for serology tests to detect for the presence of coronavirus antibodies. The EUAs were issued to Ortho-Clinical Diagnostics, Inc. for its VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Chembio Diagnostic Systems, Inc. for its DPP COVID-19 IgM/IgG System. The FDA issued...

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