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 a medical device registration certificate from the National Medical Products Administration for its nucleic acid detection kits for human bocavirus (HBoV) and human metapneumovirus (HMPV) [1] Impact on the Company - HBoV and HMPV are common respiratory viruses that can cause acute respiratory infections, particularly dangerous for children under 5 and the elderly [1] - The symptoms of these infections are similar to those of influenza and other respiratory pathogens, necessitating efficient and accurate detection methods for clinical diagnosis and treatment decisions [1] - The newly certified kits utilize multiplex fluorescent PCR technology, allowing for high sensitivity and specificity in detecting both pathogens [2] - The product enhances the company's existing respiratory infection nucleic acid rapid detection solutions, supporting precise medication for clinical use [2] - The company has over 10 years of experience in the respiratory infectious disease diagnostics field, with a product matrix covering more than 60 items [2] - The new product enriches the company's respiratory pathogen nucleic acid detection offerings and supports a flexible and comprehensive diagnostic solution for various medical institutions [2]