www.fdanews.com/articles/207483-bio-rad-laboratories-eua-for-covid-19-test-is-revoked
Bio-Rad Laboratories’ EUA for COVID-19 Test Is Revoked
April 21, 2022
The FDA has revoked the Emergency Use Authorization (EUA) it granted in February 2021 to Bio-Rad Laboratories’ Reliance SARS-CoV-2/FluA/FluB real-time polymerase chain-reaction assay kit.
The agency said the EUA was revoked at the Hercules, Calif.-based company’s request because it is no longer manufacturing or distributing the test kit. The FDA said the revocation went into effect on April 16.
The company is now making other COVID-19 tests that can distinguish the Omicron variant of the SARS-CoV-2 virus.