FDA Emergency Use Authorization Issued To Cellex For qSARS-CoV-2 IgG/IgM Rapid Test For COVID-19 Antibodies

On April 7, 2020, the U.S. Food and Drug Administration (FDA) said it authorized an Emergency Use Authorization (EUA) for a serological test that is intended for use by clinical laboratories to test for antibodies to COVID-19. The FDA authorized the first EUA for a COVID-19 rapid antibody blood test from Cellex. The FDA used its emergency powers to authorize the test, meaning a formal review is still needed. The test is available to consumers by prescription . . .