Co-Diagnostics submitted a 510(k) premarket notification for a point-of-care upper respiratory multiplex test that detects and differentiates influenza A/B, COVID-19, and RSV using nasal swab specimens. The test, Co-Dx PCR Flu A/B, and RSV upper respiratory multiplex test, is designed to run on the company’s PCR Pro point-of-care instrument. The company also requested a CLIA waiver to enable use in decentralized settings, positioning the test to reach patients outside traditional laboratory workflows. Co-Diagnostics described the submission as a step toward bringing decentralized molecular diagnostics closer to patients. If cleared and waived, the product would expand the competitive landscape for rapid multiplex respiratory testing and could strengthen adoption of point-of-care PCR platforms where turnaround time and specificity are key constraints.