诺唯赞(688105.SH):全资子公司取得2项医疗器械注册证

Core Viewpoint - The company has received two medical device registration certificates from the National Medical Products Administration for its adenovirus antigen test kits, enhancing its competitive position in the respiratory pathogen detection market [1] Group 1: Product Development - The company’s subsidiary, Nanjing Novogene Medical Technology Co., Ltd., has developed two adenovirus antigen test kits: one using colloidal gold method and the other using quantum dot fluorescence immunochromatography method [1] - These test kits are designed for auxiliary diagnosis of respiratory adenovirus infections, which are particularly harmful to children under five years old [1] Group 2: Market Positioning - The approval of the adenovirus antigen test kits complements the company's existing rapid detection solutions for respiratory pathogens, catering to various clinical needs and application scenarios [1] - The company’s quantum dot platform, combined with already certified influenza A/B antigen and respiratory syncytial virus antigen tests, enables automated and high-sensitivity detection of five core respiratory pathogens [2] - The company’s product offerings meet the rapid testing needs of grassroots medical institutions, customs, and airports, enhancing its market reach [2]