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華大基因(300676.SZ):新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)獲得巴西ANVISA認證
格隆匯 11-13 20:07

格隆匯 11 月 13日丨華大基因(300676.SZ)公佈,近日,公司全資子公司華大生物科技(武漢)有限公司的新型冠狀病毒核酸檢測產品獲得了巴西國家衞生監督局(英文全稱National Health Surveillance Agency,ANVISA)的認證。

產品名稱:Real-time fluorescent RT-PCR kit for detecting 2019-nCoV(中文譯名:新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法));註冊分類:3類醫療器械註冊證;預期用途:本試劑盒適用於定性檢測新型冠狀病毒感染的肺炎疑似患者,通過檢測從受檢者樣本中提取的核酸以確定受檢者是否有新型冠狀病毒感染。有效期限:至2030年11月12日。

新型冠狀病毒的核酸檢測是新型冠狀病毒肺炎感染確診的重要手段之一,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核酸檢測試劑盒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。

截至目前,公司該檢測產品相繼獲得中國、歐盟、美國、日本、澳大利亞、新加坡、加拿大和巴西多個國家和地區的相關資質及認證,並率先進入WHO(世界衞生組織)應急使用清單。

此次新型冠狀病毒核酸檢測試劑盒獲得巴西ANVISA認證,標誌着該產品已具備巴西市場的准入條件,進一步提升了公司產品的國際競爭力,有利於公司在全球範圍內助力新型冠狀病毒感染的肺炎疫情防控工作。

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