Coronavirus (COVID-19) Update: Daily Roundup April 15, 2020 | FDA

Coronavirus (COVID-19) Update: Daily Roundup April 15, 2020 | FDA

Coronavirus (COVID-19) Update: Daily Roundup April 15, 2020

The U.S. Food and Drug Administration today announced the following actions taken 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 an emergency use authorization (EUA) for the emergency use of Stryker Instrument’s Sterizone VP4 Sterilizer1 N95 Respirator Decontamination Cycle for use in...

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