人乳头瘤病毒核酸检测与16/18分型试剂盒(荧光PCR法)
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透景生命(300642.SZ):取得医疗器械变更注册(备案)文件
Ge Long Hui A P P· 2025-11-18 10:08
Core Viewpoint - The company, Transgen Life (300642.SZ), has received a change registration document from the National Medical Products Administration for its "Human Papillomavirus Nucleic Acid Detection and Genotyping Kit (Fluorescent PCR Method)" [1] Group 1: Product Changes - The company has completed changes related to the original registration certificate of the HPV detection kit, which now includes three new intended uses: cervical cancer primary screening, combined screening, and ASC-US triage [1] - The changes in the medical device registration are expected to better meet the diverse testing needs of end customers [1] Group 2: Market Impact - The acquisition of the medical device change registration certificate is anticipated to enhance the company's market expansion capabilities [1] - The positive impact on the company's future production and operations is highlighted as a result of these changes [1]
透景生命:取得医疗器械变更注册文件
Ge Long Hui A P P· 2025-11-18 09:52
Core Viewpoint - The company has received a change registration document from the National Medical Products Administration for its HPV nucleic acid detection kit, which is expected to enhance market expansion capabilities and positively impact future operations [1] Group 1 - The company has completed the change of registration for the "HPV Nucleic Acid Detection and Typing Kit (Fluorescent PCR Method)" [1] - The kit is designed for qualitative detection of 14 types of HPV nucleic acids in cervical exfoliated cells, specifically typing HPV16 and HPV18 [1] - This change aims to better meet the diverse testing needs of end customers [1]