Core Viewpoint - The announcement highlights the recent achievements of Oriental Bio in obtaining multiple medical device registrations for its products, enhancing its product portfolio and international market presence [1][2]. Group 1: Product Registrations - Oriental Bio's subsidiary, Shanghai Wanzijian Bio, and Healgen Scientific LLC have recently obtained medical device registrations in China, Australia, and Singapore [1]. - The domestic registrations include the Gastrin-17 test kit and the N-terminal pro B-type natriuretic peptide test kit, which assist in diagnosing atrophic gastritis and heart failure, respectively [1]. - The international registration includes Healgen's rapid test for COVID-19 and Influenza A/B antigens, suitable for individuals aged 14 and above, to be conducted within 7 days of symptom onset [1]. Group 2: Technological Advancements - The respiratory triple test kit has a sensitivity of over 90% and specificity of over 99%, marking it as a core component of Oriental Bio's global respiratory detection product matrix [1]. - Research from Emory University indicates that Healgen's triple test kit demonstrates 2 to 20 times higher sensitivity compared to other LFA products used in similar studies, with detection limits approaching molecular testing levels [1]. Group 3: Regulatory Milestones - The triple test kit is the first product to receive FDA De Novo certification in the U.S. and is also the first over-the-counter (OTC) testing product to achieve this certification [2]. - This product does not require emergency use authorization and can be self-administered by non-professional users at home [2]. - The FDA has created a new regulatory classification for this test kit, which has been recognized as one of the "Top 5 Breakthroughs in U.S. Medicine for 2024" by ABC News [2]. Group 4: Market Penetration - Healgen's triple test kit has successfully entered over 13,000 stores under Walmart, CVS, and Walgreens, as well as on Amazon and other professional channels [3]. - The product has received high praise from customers, contributing to steady market sales growth [3].