Press Releases

Ortho’s VITROS® SARS-CoV-2 Antigen Test for Accurate, Mass-Scale COVID-19 Testing is the First Widely-Available, High-Volume Test to Receive FDA Emergency Use Authorization

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that its VITROS® SARS-CoV-2 Antigen Test, designed to detect active infection, has become the first high-volume COVID-19 antigen test to receive Food and Drug Administration (FDA) Emergency Use Authorization (EUA). U.S. distribution of the test commenced in November 2020 under an FDA Emergency Use Notification (EUN); the test was also granted CE Mark in November 2020.  Read more…