Co-Diagnostics completes first FDA 510(k) application for Co-Dx PCR Pro

Co-Diagnostics announced that the company has completed its first Food and Drug Administration application for 510(k) clearance for the Co-Dx PCR Pro instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter use. The Co-Dx PCR platform “has been designed to help close the access gap for infectious disease diagnosis by facilitating the widespread decentralization of gold-standard PCR diagnostics, which have historically only been found in high-complexity clinical laboratories,” the company said in a statement. Co-Diagnostics is also preparing to shortly pursue clearance for the Co-Dx PCR COVID-19 test on the new instrument, to be used for point-of-care testing.