九安医疗甲型流感、乙型流感、COVID-19及RSV呼吸道合胞病毒四联检测家用试剂盒获FDA上市前通知

Core Viewpoint - iHealth Labs Inc., a subsidiary of the company, received pre-market notifications from the FDA for its multi-virus detection kits, indicating a significant expansion of its product offerings in the U.S. market [1][2]. Group 1: Product Development and Market Expansion - The iHealth four-in-one detection kit for influenza A, influenza B, COVID-19, and RSV has received FDA 510(k) pre-market notification, allowing it to be sold in the U.S. market [1][2]. - The three-in-one detection kit for influenza A, influenza B, and COVID-19 also received FDA 510(k) pre-market notification, which enhances its accuracy compared to previously authorized products under Emergency Use Authorization (EUA) [2]. - The transition from EUA to 510(k) ensures that the products can continue to be sold in the U.S. market even after the EUA is terminated, thus providing a stable regulatory framework for the company [2]. Group 2: Strategic Positioning and Market Demand - The company’s detection kits are positioned as regular home-use medical products for respiratory virus screening, reflecting strong consumer product characteristics [2][3]. - The company aims to meet the diverse needs of the U.S. market for respiratory virus screening, which is particularly relevant during the winter season when respiratory diseases are more prevalent [3]. - The company has expanded its sales channels beyond online platforms to include major retailers like Amazon, CVS, and Walmart, reducing reliance on government orders [3].