万孚生物(300482.SZ)：美国子公司呼吸道双联检产品获得美国FDA510(k)许可

Core Viewpoint - Wondfo USA Co., Ltd, a wholly-owned subsidiary of Wondfo Biotech, has received FDA 510(k) clearance for its dual influenza A and B home test kits, indicating a significant advancement in the company's product offerings in the U.S. market [1] Group 1: Product Approval - The FDA has granted clearance for two products: WELLlife Flu A&B Home Test (OTC version) and WELLlife Influenza A&B Test (Professional use version) [1] - The dual influenza test kits have successfully completed performance and clinical validation in the U.S., demonstrating a sensitivity exceeding 90% and a specificity of 100% [1] Group 2: Product Features - The test kits are designed for qualitative detection and differentiation of influenza A and B viruses from nasal samples within four days of respiratory symptom onset [1] - The products cater to different application needs by providing both home self-testing (OTC) and professional medical use versions, offering reliable and rapid diagnostic support [1]