万孚生物美国子公司呼吸道双联检产品获得美国FDA510许可

Core Viewpoint - Wondfo USA Co., Ltd, a wholly-owned subsidiary of Wondfo Biotech, has received FDA 510(k) clearance for two influenza test kits, marking a significant milestone in the company's product offerings in the U.S. market [1] Company Summary - Wondfo Biotech's influenza test kits include the WELLlife Flu A&B Home Test for OTC use and the WELLlife Influenza A&B Test for professional use, both designed to qualitatively detect and differentiate between influenza A and B viruses from nasal samples within four days of symptom onset [1] - The OTC version is noted as the first of its kind to receive FDA approval in the U.S. market, highlighting the company's innovative position in the healthcare sector [1]