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華大基因(300676.SZ):全資子公司新冠抗原自測產品獲得歐盟CE准入資質
格隆匯 02-07 11:49

格隆匯2月7日丨華大基因(300676.SZ)宣佈,公司全資子公司BGI Europe A/S的新冠抗原自測產品於近日取得了歐盟CE證書。產品名稱:SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)(中文譯文:新型冠狀病毒抗原檢測試劑盒(膠體金法))預期用途:用於體外定性檢測新型冠狀病毒感染疑似病例發病7天內前鼻腔拭子樣本中的新型冠狀病毒(SARS-CoV-2),輔助評估新型冠狀病毒感染狀況和臨牀診斷,適用於居家自我檢測。

公司表示,上述產品獲得歐盟CE准入資質後,可在認可歐盟CE資質的國家進行銷售,進一步豐富了公司全場景化新冠檢測綜合解決方案,有利於進一步提升公司新冠檢測產品的國際競爭力,全面助力全球新冠疫情防控。

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