Co-Diagnostics files first FDA 510(k) for Co-Dx PCR Pro platform and OTC COVID-19 test

Co-Diagnostics, Inc.

FDA receives 510(k) submission for Co-Dx PCR Pro instrument and OTC COVID-19 test.
Company plans to shortly pursue point-of-care (POC) clearance for the same test.
Other tests in pipeline include tuberculosis, HPV, strep A, and a respiratory multiplex (flu A/B, COVID-19, RSV).
CEO Dwight Egan says 510(k) clearance would validate the platform and enable commercialization.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.