Co-Diagnostics submitted a 510(k) premarket notification to the FDA for its Co-Dx PCR Flu A/B, and RSV upper respiratory multiplex test, built for self- or clinician-collected nasal swabs. The test is intended to differentiate influenza A and B alongside COVID-19 and RSV using Co-Diagnostics’ PCR Pro point-of-care instrument. The company also requested a CLIA waiver, aiming to bring decentralized molecular diagnostics closer to patient care settings. Co-Diagnostics said the submission moves it into the next phase of regulatory review while targeting broader accessibility, affordability, and ease of use for respiratory testing.