圣湘生物科技股份有限公司 关于自愿披露相关产品 取得医疗器械注册证的公告

Product Registration - The company has received medical device registration certificates for four products from the National Medical Products Administration [1] - Two of the approved respiratory "small joint inspection" products offer high sensitivity, specificity, and ease of operation, providing reports in as fast as 30 minutes [1] - The "small joint inspection" series has now expanded to 10 products, enhancing the company's "6/3+X respiratory infection nucleic acid rapid detection" system [1] Clinical Impact - The approved respiratory products are crucial for early identification of pathogens in respiratory infections, which is vital for precise medication and reducing antibiotic resistance [1] - The EB virus nucleic acid detection kit has undergone significant technical upgrades, improving detection sensitivity and supporting various specimen types [2] - The CYP3A5 gene polymorphism nucleic acid detection kit is the ninth product in the company's drug genome series, aimed at optimizing clinical medication plans for transplant patients [2]