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人偏肺病毒核酸检测试剂盒(荧光PCR法)
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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]
圣湘生物:关于自愿披露相关产品取得医疗器械注册证的公告
Zheng Quan Ri Bao· 2025-08-15 14:15
Group 1 - The company, Shengxiang Biology, announced that its products, the nucleic acid test kits for the human bocavirus and human parainfluenza virus (fluorescent PCR method), have recently received the Medical Device Registration Certificate from the National Medical Products Administration [2]