腺病毒抗原检测试剂盒(胶体金法)
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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]
硕世生物取得两项医疗器械注册证
Zhi Tong Cai Jing· 2025-09-29 09:25
Core Viewpoint - The company, Shuoshi Biotechnology (688399.SH), has received medical device registration certificates from the National Medical Products Administration for two in vitro diagnostic products, enhancing its product offerings and competitive position in the market [1]. Product Development - The newly registered products include the Adenovirus Antigen Test Kit (Colloidal Gold Method) and the Nucleic Acid Test Kit for Seven Respiratory Pathogens (Fluorescent PCR Method) [1]. - The acquisition of these medical device registration certificates expands the company's product range in the in vitro diagnostic field [1]. Market Positioning - The introduction of these products aims to meet diverse clinical needs, thereby strengthening the company's overall competitiveness [1]. - This development is expected to improve the company's market expansion capabilities [1].
硕世生物(688399.SH)取得两项医疗器械注册证
智通财经网· 2025-09-29 09:21
Core Viewpoint - The company, Shuoshi Biotechnology (688399.SH), has received a medical device registration certificate from the National Medical Products Administration for two in vitro diagnostic products, enhancing its product offerings and competitive position in the market [1] Product Development - The newly registered products include the Adenovirus Antigen Test Kit (Colloidal Gold Method) and the Nucleic Acid Test Kit for Seven Respiratory Pathogens (Fluorescent PCR Method) [1] - The acquisition of these medical device registration certificates expands the company's portfolio in the in vitro diagnostic field [1] Market Positioning - The introduction of these products aims to meet diverse clinical needs, thereby strengthening the company's overall competitiveness [1] - This development is expected to enhance the company's market expansion capabilities [1]