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.
| SAN DIEGO, Dec. 1, 2022 /PRNewswire/ -- 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. For more information about the CorDx COVID-19 AG Test or to inquire about wholesale opportunities, visit cordx.com. About CorDx: From its headquarters in Atlanta, Ga., CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world. Through its product realization partnerships with leading pharmaceutical companies, CorDx develops, manufactures, and distributes diagnostics and related tools that empower users to monitor and improve their health. Its proprietary line of diagnostics solutions is recognized by families and medical professionals for their reliability, affordability, and rapid results. CorDx is a member of the CorDx Union, a biotechnology organization that delivers medical device solutions to healthcare industries and over a billion users in more than 170 countries. To learn more, visit CorDx.com. For more information contact: Shuang Wills
SOURCE CorDx |
View original content to download multimedia:
