万孚生物：全自动核酸扩增分析仪获批上市

Core Viewpoint - Wanfu Bio's U-CardDx 200 fully automatic nucleic acid amplification analyzer has received NMPA Class III medical device registration approval for market launch, marking a significant advancement in molecular diagnostics [1] Company Summary - The U-CardDx 200 system has also obtained EU CE IVDR certification and is already in operation in multiple countries overseas [1] - This device utilizes classic magnetic bead nucleic acid extraction and real-time fluorescence quantitative PCR technology, innovatively reducing the total nucleic acid testing time to 15 minutes [1] - The U-CardDx 200 serves as a complete molecular diagnostic laboratory in a single instrument, capable of meeting routine testing needs and addressing urgent testing demands during peak periods [1] Industry Summary - Molecular diagnostics is a key strategic platform for Wanfu Bio, driving precision medicine [1] - The approval of the U-CardDx 200 signifies a new era in nucleic acid testing and opens a new chapter in molecular diagnostics, providing hospitals and laboratories with more efficient and precise testing tools [1]