圣湘生物:人冠状病毒、副流感病毒、新型冠状病毒核酸检测试剂盒获得医疗器械注册证

Core Viewpoint - The company, Shengxiang Bio, has received a medical device registration certificate from the National Medical Products Administration for its nucleic acid test kit designed to detect human coronaviruses, parainfluenza viruses, and the novel coronavirus, which is expected to enhance the diagnosis of infectious diseases and support clinical precision medication and antibiotic management [1] Group 1 - The product is intended for in vitro qualitative detection of nucleic acids from human coronaviruses, parainfluenza viruses, and the novel coronavirus in throat swab samples from individuals exhibiting symptoms of infection [1] - The approval of this product is anticipated to improve the level of diagnosis for infectious diseases [1] - There is uncertainty regarding the future market performance of the product [1]