www.fdanews.com/articles/196534-co-diagnostics-covid-19-test-gets-eua
Co-Diagnostics’ COVID-19 Test Gets EUA
April 7, 2020
The FDA has granted Co-Diagnostics an emergency use authorization for its COVID-19 test.
The Logix Smart test, which previously received a CE Mark, is now cleared for use in the U.S. by certified clinical laboratories.
The test targets the RdRp gene of the coronavirus and uses the company’s patented technology to significantly reduce amplification errors.