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丽珠医药(01513.HK)新型冠状病毒检测试剂进入快速审批通道
阿思达克 02-14 04:54

丽珠医药(01513.HK)公布,控股附属丽珠试剂为积极应对新型冠状病毒疫情防控的需求,针对诊断环节积极组织团队开展相关病毒核酸和抗体检测试剂产品和配套设备的研发申报及临床应用推广工作。

本月9日,丽珠试剂与中国科学院武汉病毒研究所联合研制的新型冠状病毒IgM抗体检测试剂(胶体金法)、新型冠状病毒IgG抗体检测试剂(胶体金法)已通过体外诊断试剂应急审批答辩,并於本月11日正式进入快速审批通道,待取得注册证後即可展开量产并加急投入临床一线使用。

另外,,由中国食品药品检定研究院、中国科学院武汉病毒研究所和丽珠试剂共同申报的科技部应急项目,新型冠状病毒IgM抗体检测试剂盒((酉每)联免疫法)也於本月11日正式进入国家应急审批通道。

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