Co-diagnostics, inc. submits first fda 510(k) application for co-dx pcr pro platform

The company expects that the application for otc clearance will shortly be followed by pursuit of poc clearance, with other tests in the pipeline to meet the needs of a global market salt lake city , june 14, 2024 /prnewswire/ -- co-diagnostics, inc. (nasdaq: codx) (the "company" or "co-dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that the company has completed its first u.s. food and drug administration (fda) application for 510(k) clearance for the co-dx™ pcr pro™ instrument, and the co-dx pcr covid-19 test for over-the-counter (otc) use. co-diagnostics completed the submission via the fda's electronic submissions template and resource (estar) system, and have received the acknowledgement from the fda that the 510(k) application was received.
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