人冠状病毒

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圣湘生物科技股份有限公司关于自愿披露相关产品取得医疗器械注册证的公告
Shang Hai Zheng Quan Bao· 2025-10-08 19:14
Core Viewpoint - The company has received a medical device registration certificate for its nucleic acid test kits for human coronaviruses, influenza viruses, and novel coronaviruses, which are essential for accurate diagnosis and treatment of respiratory infections [1][2]. Product Registration Details - The newly certified test kits utilize multiplex fluorescent PCR technology, offering high sensitivity, specificity, and ease of use, capable of accurately identifying three pathogens in as little as 30 minutes [2]. - The product line integrates with the company's existing rapid detection solutions for respiratory infections, allowing for unified sampling and amplification, thus enabling simultaneous detection of various common respiratory pathogens [2]. Impact on the Company - The test kits address the clinical challenges posed by respiratory pathogens, which often present similar symptoms, making accurate diagnosis difficult. The need for efficient and precise testing methods is critical for clinical decision-making [1][2]. - The company aims to enhance its product offerings in respiratory infection diagnostics, contributing to improved treatment levels for infectious diseases and supporting public health efforts against antimicrobial resistance [2].
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
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-30 08:15
南财智讯9月30日电,圣湘生物公告,公司收到国家药品监督管理局颁发的《医疗器械注册证》,产品 名称为人冠状病毒、副流感病毒、新型冠状病毒核酸检测试剂盒(荧光PCR法)。该产品用于体外定性 检测具有新型冠状病毒感染或其他呼吸道感染相关症状人群的咽拭子样本中的人冠状病毒、副流感病毒 和新型冠状病毒的核酸。产品的获批有助于提升感染性疾病诊疗水平,为临床精准用药和抗菌药物管理 提供有力支撑。但产品未来的市场表现存在不确定性。 ...
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。 ...