CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and other medical devices, recently received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 Ag Test designed for non-prescription home use and featuring a 10-minute time to result.
The CorDx COVID-19 Ag Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.
“We take any threat to public health seriously. CorDx’s foremost mission is to develop, manufacture, and distribute reliable, affordable diagnostic products that protect health and save lives,” said Jeff Yufeng Li, CorDx’s founder & CEO. “We’re honored to utilize our integrated supply chain to provide the CorDx COVID-19 Ag Test to families in the United States.”
The CorDx COVID-19 Ag Test has not been FDA cleared or approved. This test is authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Source: Company Press Release
