www.fdanews.com/articles/196002-co-diagnostics-coronavirus-test-earns-ce-mark
Co-Diagnostics’ Coronavirus Test Earns CE Mark
February 25, 2020
Co-Diagnostics’ Logix Smart coronavirus COVID-19 test has been cleared for marketing in Europe as an in vitro diagnostic.
The development of the diagnostic was announced only a month ago and was accelerated using the Salt Lake City, Utah company’s patented technology, which dramatically reduces amplification errors during testing, the company said.
“We believe Co-Diagnostics is the first U.S. company to receive a CE-marking for a coronavirus IVD,” said CEO Dwight Egan.