華大基因(300676.SZ):新型冠狀病毒核酸檢測產品獲得澳大利亞TGA註冊
格隆匯4月15日丨華大基因(300676.SZ)公佈,公司全資子公司BGI Health (AU)Company Pty Ltd(以下簡稱"澳洲華大")的新型冠狀病毒核酸檢測產品獲得了澳大利亞藥物管理局(英文全稱"Therapeutic Goods Administration",以下簡稱"TGA")的註冊。
新型冠狀病毒的核酸檢測是新型冠狀病毒肺炎感染診斷的重要手段之一,新型冠狀病毒核酸檢測試劑盒是目前各國進行體外定性檢測新型冠狀病毒感染的肺炎疑似病例和其他需要進行新型冠狀病毒感染鑑別診斷者的主要方法。公司研發的新型冠狀病毒SARS-CoV-2核酸檢測試劑盒(熒光PCR法)可實現病毒的快速檢測,協助各國當局和醫療機構等採取及時有效的防控措施,較好地滿足各國疫情防控的市場需求。
此前,公司該檢測產品已取得了中國國家藥品監督管理局頒發的醫療器械註冊證,完成了歐盟CE認證,並獲得了歐盟自由銷售證書,同時,該產品已獲得了美國食品藥品監督管理局(以下簡稱"FDA")簽發的緊急使用授權(EUA),通過了日本PMDA認證。
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