10/15/2026
Today, we are pleased to announce that the CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test has received FDA 510(k) clearance for both OTC and Rx versions. Transitioning from EUA to 510(k) clearance marks an important regulatory milestone, supporting continued market availability beyond the emergency authorization framework and reaffirming CorDxโs commitment to quality, regulatory compliance, and accessible respiratory diagnostics.
With both OTC and Rx versions cleared, the test offers flexible testing options for consumers and healthcare professionals across home and clinical settings.
One test. Three respiratory pathogens. Advancing accessible respiratory diagnostics.
For stock availability and pricing information, please contact your Sales representative.