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腺病毒抗原检测试剂盒(量子点荧光免疫层析法)
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诺唯赞(688105.SH):全资子公司取得2项医疗器械注册证
Ge Long Hui A P P· 2025-11-06 09:21
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]
诺唯赞:2款产品获得医疗器械注册证
Core Viewpoint - The company announced that its wholly-owned subsidiary, Nanjing Novogene Medical Technology Co., Ltd., received two medical device registration certificates from the National Medical Products Administration for adenovirus antigen test kits, enhancing its competitive position in the respiratory pathogen rapid testing market [1] Group 1: Product Approval - The two approved products are adenovirus antigen test kits using colloidal gold method and quantum dot fluorescence immunochromatography method, intended for in vitro qualitative detection of adenovirus antigens in throat swab samples [1] - The approval of these products is seen as a valuable addition to the company's existing respiratory pathogen rapid testing solutions [1] Group 2: Market Impact - The new products are expected to meet the testing needs of different healthcare settings, including grade hospitals and grassroots medical institutions, by leveraging both the quantum dot and colloidal gold platforms [1] - The specific sales performance of the products post-launch will be influenced by market conditions, commercialization efforts, and channel development, with the company indicating that the short-term impact on operational performance is expected to be minimal [1] - The company is currently unable to predict the long-term impact of these products on its future performance [1]
诺唯赞:全资子公司取得医疗器械注册证
Xin Lang Cai Jing· 2025-11-06 09:04
Core Viewpoint - The company, Novogene, announced that its wholly-owned subsidiary, Nanjing Novogene Medical Technology Co., Ltd., has received two Class III medical device registration certificates from the National Medical Products Administration for adenovirus antigen test kits, enhancing its market competitiveness in the respiratory adenovirus infection diagnostic field [1] Group 1 - The products involved are adenovirus antigen test kits using colloidal gold method and quantum dot fluorescence immunochromatography method [1] - The registration certificates are valid until November 3, 2030 [1] - The products are intended for auxiliary diagnosis of respiratory adenovirus infections [1]