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.
Related News Articles
Headline
The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following…
Headline
The Advisory Committee on Immunization Practices Sept. 19 recommended that patients should consult their health care provider if they want to receive a COVID-…
Headline
The Department of Health and Human Services Sept. 18 announced it will take new actions to help improve care for individuals with long COVID. They include a…
Headline
The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore…
Headline
The Centers for Disease Control and Prevention is predicting a similar combined number of peak hospitalizations from COVID-19, the flu and respiratory…
Headline
The Occupational Safety and Health Administration today announced a 60-day extension of the comment period on its proposed rule to remove the remaining…