万孚生物美国子公司呼吸道双联检产品获得美国FDA 510许可

Core Insights - Wanfu Bio has successfully obtained FDA 510(K) approval for two respiratory testing products, marking a significant milestone in its international expansion efforts [1][2] Product Details - The approved products include the WELLlife Flu A&B Home Test (OTC version) and the WELLlife Influenza A&B Test (Professional use version), both of which have demonstrated over 90% sensitivity and 100% specificity in detecting influenza A and B viruses [2] - These products are designed for qualitative detection and differentiation of influenza viruses using nasal samples within four days of respiratory symptom onset, catering to both home testing and professional medical use [2] Market Implications - The OTC version is the first of its kind to receive FDA approval in the U.S. market, which will enhance product accessibility through various sales channels including e-commerce, pharmacies, and supermarkets [2] - This approval not only highlights Wanfu Bio's continuous innovation in respiratory diagnostics but also enriches its product portfolio in the U.S. market, providing comprehensive solutions for the prevention and control of respiratory infectious diseases [2]