Co-Diagnostics filed a 510(k) submission to the FDA for a point-of-care upper respiratory infection test that can differentiate influenza A/B, COVID-19, and RSV using nasal swab samples. The Co-Dx PCR Flu A/B, and RSV multiplex test runs on the company’s PCR Pro platform and is paired with a CLIA waiver request to support decentralized use. The submission outlines a regulatory push to make molecular respiratory testing more accessible in clinic and other settings outside centralized labs. Co-Diagnostics said the program aims to improve affordability and ease of use while moving through the next step of its regulatory pathway. If cleared, the test could accelerate respiratory pathogen workflows where turnaround time and triage decisions depend on rapid, multiplexed detection.