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诺唯赞子公司取得两项医疗器械注册证
Zhi Tong Cai Jing· 2025-11-06 09:16
Core Viewpoint - The approval of two medical device registration certificates for adenovirus antigen test kits enhances the company's respiratory pathogen rapid testing solutions, improving market competitiveness in the relevant field [1] Group 1: Product Development - The company’s subsidiary received two medical device registration certificates from the National Medical Products Administration for adenovirus antigen test kits using colloidal gold and quantum dot fluorescence immunochromatography methods [1] - The new adenovirus antigen test kits complement existing rapid testing solutions, catering to various application scenarios and clinical needs [1] Group 2: Technological Advancements - The quantum dot platform, combined with already certified influenza A/B antigen, respiratory syncytial virus antigen, and Mycoplasma pneumoniae antibody test kits, enables fully automated, high-sensitivity, quantitative detection of five core respiratory pathogens [1] - The automated fluorescence immunoassay system allows for sample input and result output, meeting the demand for large-scale automated testing in higher-level hospitals [1] Group 3: Market Applications - The colloidal gold platform for respiratory pathogen detection includes influenza A/B antigens, respiratory syncytial virus antigens, adenovirus antigens, and Mycoplasma pneumoniae antibody test kits, addressing rapid testing needs in primary healthcare institutions, customs, and airports [1]
诺唯赞(688105.SH)子公司取得两项医疗器械注册证
智通财经网· 2025-11-06 09:14
Core Insights - The company, Novogene (688105.SH), announced that its wholly-owned subsidiary, Nanjing Novogene Medical Technology Co., Ltd., has received two medical device registration certificates from the National Medical Products Administration for adenovirus antigen test kits using colloidal gold method and quantum dot fluorescence immunochromatography method [1] Group 1: Product Development - The approval of the adenovirus antigen test kits enhances the company's existing rapid detection solutions for respiratory pathogens, catering to various application scenarios and clinical needs [1] - The quantum dot platform, combined with already certified influenza A/B antigen, respiratory syncytial virus antigen, and Mycoplasma pneumoniae antibody test kits, enables fully automated, high-sensitivity, quantitative detection of five core respiratory pathogens [1] - The automated fluorescence immunoassay analyzer allows for a streamlined process where samples are input and results are output, meeting the demand for large-scale automated testing in higher-tier hospitals [1] Group 2: Market Positioning - The quantitative detection improves testing efficiency and visualizes disease progression, better addressing clinical needs for precision treatment and medication [1] - The colloidal gold platform's respiratory pathogen detection series includes influenza A/B antigens, respiratory syncytial virus antigens, adenovirus antigens, and Mycoplasma pneumoniae antibody test kits, fulfilling rapid testing requirements in various settings such as grassroots medical institutions, customs, and airports [1]
诺唯赞:2款产品获得医疗器械注册证
2 1 Shi Ji Jing Ji Bao Dao· 2025-11-06 09:09
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]