Co-Diagnostics filed a 510(k) premarket notification with the FDA for its point-of-care upper respiratory infection test, Co-Dx PCR Flu A/B, and RSV. The assay is designed to differentiate influenza A and B, COVID-19, and RSV from self- or clinician-collected nasal swab samples. The company also requested a CLIA waiver to enable use in decentralized settings, aiming to expand access beyond central lab workflows. Co-Diagnostics framed the submission as part of a broader push to bring molecular testing closer to patients with an emphasis on accessibility and ease of use. If cleared, the test would add to the growing catalog of multiplex respiratory platforms targeting faster triage during peak respiratory seasons.