FDA actions authorize serology tests, N95 sterilization process

The Food and Drug Administration this week issued a pair of emergency use authorizations 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.

FDA also authorized the emergency use of Stryker Instrument’s Sterizone VP4 Sterilizer1 N95 Respirator Decontamination Cycle for single reuse by health care personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators.