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麗珠集團(000513.SZ):新型冠狀病毒IgM抗體檢測試劑盒(酶聯免疫法)於2月11日正式進入國家應急審批通道
格隆匯 02-13 17:52

格隆匯2月13日丨麗珠集團(000513.SZ)公佈,2019年末,湖北省武漢市爆發了新型冠狀病毒肺炎疫情。公司控股附屬公司珠海麗珠試劑股份有限公司(“麗珠試劑”)為積極應對新型冠狀病毒疫情防控的需求,針對新型冠狀病毒的診斷環節,積極組織團隊開展相關病毒核酸和抗體檢測試劑產品和配套設備的研發申報及臨牀應用推廣工作。現將有關進展詳情公告如下:

2020年2月9日,麗珠試劑與中國科學院武漢病毒研究所聯合研製的新型冠狀病毒IgM抗體檢測試劑(膠體金法)、新型冠狀病毒IgG抗體檢測試劑(膠體金法)已通過體外診斷試劑應急審批答辯,並於2月11日正式進入快速審批通道,待取得註冊證後即可展開量產並加急投入臨牀一線使用。另,由中國食品藥品檢定研究院、中國科學院武漢病毒研究所和麗珠試劑共同申報的科技部應急項目,新型冠狀病毒IgM抗體檢測試劑盒(酶聯免疫法)也於2月11日正式進入國家應急審批通道。

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