新型冠状病毒核酸检测试剂盒(荧光PCR法)

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圣湘生物产品取得医疗器械注册证
Zhi Tong Cai Jing· 2025-09-30 08:15
Core Viewpoint - Shengxiang Bio (688289.SH) has received a medical device registration certificate from the National Medical Products Administration for its nucleic acid test kits for human coronavirus, parainfluenza virus, and novel coronavirus, utilizing multiplex fluorescent PCR technology [1] Group 1: Product Features - The nucleic acid test kits demonstrate high sensitivity, high specificity, and ease of operation, capable of accurately identifying three pathogens in as little as 30 minutes [1] - The product can be integrated with the company's existing rapid detection solutions for respiratory infections, allowing for unified sampling and amplification to detect multiple common respiratory pathogens simultaneously [1] Group 2: Application and Market Scope - This series of products covers common respiratory viruses, bacteria, fungi, atypical pathogens, and drug resistance genes, making it suitable for outpatient, emergency, and inpatient settings [1] - The kits support flexible combinations of different testing products based on patient clinical presentations, regional characteristics, and seasonal prevalence, effectively addressing complex situations of co-circulation and mixed infections, thereby providing strong support for precise medication and antibiotic management in clinical settings [1]
圣湘生物(688289.SH)产品取得医疗器械注册证
智通财经网· 2025-09-30 08:15
智通财经APP讯,圣湘生物(688289.SH)发布公告,公司的产品人冠状病毒、副流感病毒、新型冠状病 毒核酸检测试剂盒(荧光PCR法)于近日收到由国家药品监督管理局颁发的《医疗器械注册证》。 公司本次获证的人冠状病毒、副流感病毒、新型冠状病毒核酸检测试剂盒采用多重荧光PCR技术,具备 高灵敏度、高特异性、操作简便等优势,最快可在30分钟内完成3种病原的精准鉴别。该产品可结合公 司现有的呼吸道感染核酸快速检测方案,统一采样、统一扩增,实现多种常见呼吸道病原体同步检测。 该系列产品已覆盖常见呼吸道病毒、细菌、真菌、非典型病原体及耐药基因,广泛适用于门诊、急诊及 住院等多种场景,同时支持基于患者临床表现、地域及季节流行特征,灵活组合不同检测产品,更好应 对多病原共流行和混合感染等复杂局面,为临床精准用药和抗菌药物管理提供有力支撑。 ...