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甲型流感病毒/乙型流感病毒/呼吸道合胞病毒核酸检测试剂盒(荧光PCR法)
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万孚生物:甲型流感病毒/乙型流感病毒/呼吸道合胞病毒核酸检测试剂盒获证
Zhong Zheng Wang· 2025-09-10 13:56
Core Viewpoint - Wanfu Bio has received a medical device registration certificate from the National Medical Products Administration for its nucleic acid test kit for influenza A virus, influenza B virus, and respiratory syncytial virus, marking a significant advancement in respiratory pathogen detection [1] Group 1: Product Development - The nucleic acid test kit is a crucial breakthrough in the field of respiratory pathogen detection, enhancing the company's diagnostic product lineup and strengthening its competitive edge in the in vitro diagnostic sector [1] - On August 21, Wanfu Bio's U-CardDx200 fully automated nucleic acid amplification analyzer received NMPA Class III medical device registration approval, showcasing the company's commitment to innovation in molecular diagnostics [1] Group 2: Technological Innovation - The U-CardDx200 utilizes classic magnetic bead nucleic acid extraction and real-time fluorescence quantitative PCR technology, reducing the total nucleic acid testing time to 15 minutes, effectively functioning as a molecular diagnostic laboratory [1] - This device is designed to meet routine testing needs while also being capable of handling urgent testing demands during peak periods [1]
万孚生物(300482.SZ):取得产品注册证
Ge Long Hui A P P· 2025-09-10 12:37
Core Viewpoint - Wanfu Bio (300482.SZ) has received a medical device registration certificate from the National Medical Products Administration for a nucleic acid detection kit for influenza A virus, influenza B virus, and respiratory syncytial virus (RSV), marking a significant advancement in respiratory pathogen detection [1] Group 1: Product Development - The newly approved product is a key breakthrough in the field of respiratory pathogen detection, which is crucial for addressing acute respiratory infections globally [1] - The product utilizes fluorescent PCR technology, aligning with the company's strategic focus on molecular diagnostics as a core driver of precision medicine [1] Group 2: Competitive Positioning - This new kit will complement the existing product line, enhancing the respiratory disease detection matrix and strengthening the company's overall competitiveness in the in vitro diagnostics sector [1]