九安医疗(002432.SZ):美国子公司四联检、三联检产品获得美国FDA上市前通知

Core Viewpoint - The company Jiuan Medical (002432.SZ) announced that its U.S. subsidiary, iHealth Labs Inc., received pre-market notifications from the FDA for two types of diagnostic test kits for respiratory viruses, indicating a significant step in product development and potential market entry [1]. Group 1: Product Announcements - iHealth Labs Inc. received FDA 510(K) pre-market notifications for a four-in-one home test kit that detects Influenza A, Influenza B, COVID-19, and RSV [1]. - The company also received FDA 510(K) pre-market notifications for a three-in-one home test kit that detects Influenza A, Influenza B, and COVID-19 [1].