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

Core Viewpoint - The company announced that its U.S. subsidiary, iHealth Labs Inc., received pre-market notifications from the FDA for several home and professional use testing kits for respiratory viruses, indicating a significant step towards market entry in the U.S. [1] Group 1: Product Announcements - The company’s iHealth U.S. subsidiary received FDA pre-market notifications for a four-in-one testing kit for Influenza A, Influenza B, COVID-19, and RSV, allowing for normal sales in the U.S. market [1] - Additionally, the company received FDA pre-market notifications for a three-in-one testing kit for Influenza A, Influenza B, and COVID-19, which also permits normal sales in the U.S. market [1]