Co-Diagnostics withdraws COVID-19 test 510(k) application; to submit enhanced version

Co-Diagnostics, Inc.

Withdrew current 510(k) application for Co-Dx PCR COVID-19 Test after FDA feedback on component shelf-life stability.
Plans to submit an enhanced version for OTC clearance after collecting new clinical evaluation data.
Enhanced version to incorporate recent PCR platform developments to improve manufacturing efficiencies.
Pipeline includes upcoming tests for tuberculosis, upper-respiratory multiplex, and HPV.
No specific timeline provided for the new submission.

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.