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

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]