Wantai Biological: U.S. subsidiary's influenza virus dual detection product receives FDA 510 approval.

Wondfo Biotech announced that its US subsidiary, Wondfo USA Co., Ltd, recently received notification from the US Food and Drug Administration (FDA) that its Influenza A and Influenza B dual antigen home test kit and its Influenza A and Influenza B dual antigen test kit have both obtained FDA 510 clearance. The detection sensitivity of both virus markers exceeds 90%, with a specificity of 100%, and overall performance is excellent. The product is suitable for testing nasal samples taken within 4 days of respiratory symptoms appearing, and can qualitatively detect and differentiate between Influenza A and Influenza B viruses. It is available in both a home self-testing version and a professional medical setting version.