華大基因(300676.SZ):控股子公司新冠抗體檢測產品取得醫療器械註冊證
格隆匯6月18日丨華大基因(300676.SZ)公佈,公司控股子公司北京華大吉比愛生物技術有限公司(以下簡稱“北京吉比愛”)的新型冠狀病毒(2019-nCoV)IgM/IgG抗體檢測試劑盒(酶聯免疫法)(以下簡稱“新冠抗體檢測試劑盒”)於近日取得了國家藥品監督管理局(以下簡稱“國家藥監局”)頒發的醫療器械註冊證。
該產品用於體外定性檢測人血清或血漿中新型冠狀病毒(2019-nCoV)IgM/IgG抗體。僅用於對新型冠狀病毒核酸檢測陰性疑似病例的補充檢測指標或疑似病例診斷中與核酸檢測協同使用,不能作為新型冠狀病毒感染的肺炎確診和排除的依據,不適用於一般人羣的篩查。產品僅限新型冠狀病毒感染的肺炎疫情期間臨牀使用和應急儲備,不能作為常規體外診斷試劑應用於臨牀。產品僅限醫療機構使用。
截至目前,公司已具有三項獲國家藥監局批准的新冠檢測試劑盒,分別是基於新型冠狀病毒2019-nCoV核酸檢測試劑盒(聯合探針錨定聚合測序法)、新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)和新型冠狀病毒(2019-nCoV)IgM/IgG抗體檢測試劑盒(酶聯免疫法)。
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