Co-Diagnostics Completes Clinical and Analytical Studies in Preparation for FDA 510(k) Submission of Upper Respiratory Point-of-Care Test
More than 1,400 patients enrolled across 9 clinical sites; analytical performance testing included 27 individual studies and over 10,000 PCR test cup runsAnalytical data to support concurrent 510(k) submission with CLIA Waiver by Application for point-of-care settings, with submission targeted for…