復星醫藥(02196.HK)新冠病毒核酸檢測試劑盒通過藥監局應急審批
復星醫藥(02196.HK)公布,全資子公司上海復星長征研製的新型冠狀病毒核酸檢測試劑盒已通過藥監局應急審批,取得醫療器械產品註冊證。
公司表示,檢測試劑可對新型冠狀病毒ORF1ab、N、E三個基因靶標的全自動操作定性檢測,通過配套快速核酸提取儀及提取試劑,2小時內完成96個樣本的全部檢測,自動化檢測能減少操作人員被感染風險,減少實驗室交叉污染風險,提高檢測效率。核酸檢測試劑已於3月17日通過歐盟CE認證,具備歐盟市場的准入條件。
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