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 an emergency use authorization (EUA) for the emergency use of Stryker Instrument’s Sterizone VP4 Sterilizer1 N95 Respirator Decontamination Cycle for use in decontaminating compatible N95 and N95-equivalent respirators for single-user reuse by healthcare personnel.
