据介绍，甲型流感病毒、乙型流感病毒与呼吸道合胞病毒(RSV)是引起全球急性呼吸道感染的主要病原 体。分子诊断更是作为万孚生物战略布局的前沿技术平台，是精准医疗的核心驱动力。该产品是公司在 呼吸道病原体检测领域的重要突破，可与现有产品线形成协同，进一步完善呼吸道疾病检测矩阵，强化 公司在体外诊断领域的综合竞争力。 此外，8月21日，万孚生物自主研发的U-CardDx200全自动核酸扩增分析仪获NMPA第三类医疗器械注 册批准上市。U-CardDx200依托经典的磁珠法核酸提取与实时荧光定量PCR技术，通过技术与设计创 新，将全流程核酸检测时间缩短至15分钟。一台仪器就是一个分子诊断实验室，既能满足日常检测所 需，又能应对高峰期的紧急检测需求。 中证报中证网讯(王珞)9月10日晚间，万孚生物（300482）发布公告称，公司甲型流感病毒/乙型流感病 毒/呼吸道合胞病毒核酸检测试剂盒(荧光PCR法)收到国家药品监督管理局颁发的医疗器械注册证。 ...

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]