Core Viewpoint - The company, Tuojing Life (300642), has received a change registration document from the National Medical Products Administration for its HPV nucleic acid detection kit, indicating an expansion in the product's intended use [1] Group 1: Product Changes - The product's new intended use includes qualitative detection of 14 high-risk HPV types in cervical exfoliated cells and specific typing for HPV16 and HPV18 [1] - The kit can be used for screening patients with ASC-US results from cervical cytology to determine the need for colposcopy [1] - For women aged 30 and above, the product can be combined with cytological history and other risk factors for cervical cancer primary screening, joint screening, and patient management [1]
透景生命:收到医疗器械变更注册文件