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EB 病毒核酸检测试剂盒(荧光 PCR 法)
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圣湘生物:相关产品取得医疗器械注册证及欧盟CE认证
Ge Long Hui· 2025-11-07 10:23
Core Insights - Shengxiang Bio (688289.SH) has recently obtained three product certifications and registrations, including two Class III medical device registrations and one EU CE IVDR certification [1][2] - The newly launched products include a Norovirus nucleic acid detection kit and a combined detection kit for A group rotavirus, Norovirus, and F group enteric adenovirus, which will enhance rapid identification and precise diagnosis of diarrheal pathogens [1] - The EB virus nucleic acid detection kit has received EU CE IVDR certification, expanding the company's herpes virus testing product line and demonstrating compliance with international quality and technical standards [2] Product Certifications - The products certified include: - Norovirus nucleic acid detection kit (PCR-fluorescent probe method), registration number: 国械注准20253402188 - A group rotavirus/Norovirus/F group enteric adenovirus nucleic acid detection kit (PCR-fluorescent probe method), registration number: 国械注准20253402226 - EB virus nucleic acid detection kit (fluorescent PCR method), registration number: No.V120745520012Rev.00 [1] Market Impact - The introduction of these products is expected to significantly improve clinical capabilities in diagnosing diarrheal pathogens, particularly benefiting vulnerable populations such as children and the elderly [1] - The EB virus is commonly associated with various diseases, including infectious mononucleosis and several types of cancer, highlighting the importance of the newly certified detection kit in public health [2] - The company aims to accelerate the global rollout of innovative products, contributing to public health and precision medicine [2]