The U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) to San Diego-based CorDx for the nonprescription home use of its COVID-19 Ag Test, the firm said on Thursday.
Its COVID-19 Ag lateral flow immunoassay provides qualitative detection of the nucleocapsid protein antigen from the SARS-CoV-2 virus, providing a result in 10 minutes, the firm added.
"CorDx's foremost mission is to develop, manufacture, and distribute reliable, affordable diagnostic products that protect health and save lives," Jeff Yufeng Li, CorDx's founder and CEO, said in a statement.