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樂普醫療(300003.SZ):新型冠狀病毒抗體檢測試劑盒(膠體金免疫層析法)取得歐盟CE認證
格隆匯 03-12 19:00

格隆匯3月12日丨樂普醫療(300003.SZ)公佈,公司於今日獲悉,公司全資子公司北京樂普醫療科技有限責任公司(“樂普科技”)自主研發的新型冠狀病毒(SARS-CoV-2)抗體檢測試劑盒(膠體金免疫層析法)獲得歐盟CE准入,取得歐盟市場準入資格。

該款產品運用膠體金免疫層析技術,定性檢測臨牀樣本(血清/血漿/全血)中新型冠狀病毒(SARS-CoV-2)抗體的含量,為新冠肺炎的疑似患者、隔離或醫學觀察和其他需要進行新型冠狀病毒感染診斷或鑑別診斷者提供快速、準確、便捷的現場檢測手段。

今年2月公司下屬子公司北京愛普益醫學檢驗中心有限公司入選北京市第三批開展新型冠狀病毒核酸檢測單位,此次樂普科技該款產品的獲批,體現了公司全力支持抗擊新型冠狀病毒疫情下的產品研發和供給能力,能滿足全球各國疫情快速檢測防控需求,為全球新冠疫情防控工作保駕護航。公司將盡快推進該產品在國內的註冊上市,盡力幫助疾控中心、有條件的檢驗科及第三方檢驗機構,共同搭建新型冠狀病毒核酸檢測平台,提高核酸檢測能力。

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