九安医疗美国子公司四联检、三联检产品获美国FDA上市前通知

Core Viewpoint - The company Jiuan Medical (002432.SZ) announced that its U.S. subsidiary, iHealth Labs Inc., has received pre-market notifications from the U.S. Food and Drug Administration (FDA) for several diagnostic test kits, allowing them to be sold in the U.S. market [1] Group 1: Product Approvals - The following products received FDA 510(K) pre-market notifications: 1. A four-in-one home test kit for detecting Influenza A, Influenza B, COVID-19, and RSV (Respiratory Syncytial Virus) [1] 2. A four-in-one professional test kit for the same viruses [1] - Additionally, a three-in-one home test kit for Influenza A, Influenza B, and COVID-19, as well as a three-in-one professional test kit, also received FDA 510(K) pre-market notifications [1]