智通财经APP讯，圣湘生物(688289.SH)发布公告，公司的四款产品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》，包括呼吸道合胞病毒核酸检测试剂盒(荧光PCR法)、甲型流感病毒、乙型流感病毒、腺病毒核酸检测试剂盒(荧光PCR法)、甲型流感病毒、乙型流感病毒、肺炎支原体核酸检测试剂盒(荧光PCR法)和人鼻病毒、腺病毒、肺炎支原体核酸检测试剂盒(荧光PCR法)。
公司本次获证的四款产品均采用多重荧光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分钟内完成精准鉴别。至此，公司“小联检”系列产品已扩展至8款，进一步完善了圣湘“6/3+X呼吸道感染核酸快速检测”体系，可实现统一采样、统一扩增、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。
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