華大基因(300676.SZ):新型冠狀病毒核酸檢測試劑盒獲得新加坡HSA的臨時授權
格隆匯5月6日丨華大基因(300676.SZ)公佈,公司全資子公司BGI Health (SG) Company Pte Ltd(“新加坡華大”)於近日收到新加坡衞生科學局(英文全稱“Health Sciences Authority”,“HSA”)簽發的臨時授權書,公司新型冠狀病毒核酸檢測試劑盒獲得了新加坡HSA的臨時授權。
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))
預期用途:本試劑盒用於體外定性檢測新型冠狀病毒感染的肺炎疑似病例、疑似聚集性病例患者、其他需要進行新型冠狀病毒感染診斷或鑑別診斷者的肺泡灌洗液和咽拭子樣本中,新型冠狀病毒(2019-nCoV)ORF1ab基因。
該授權為現行新型冠狀病毒肺炎感染疫情之下的產品供應臨時授權,如申請者在新加坡市場長期銷售該產品,需另行取得新加坡HSA的產品註冊;製造商需符合ISO 13485質量體系。
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。
截至公告披露日,共計三十餘家國內外企業的新型冠狀病毒產品獲得了新加坡HSA的臨時授權,包括公司在內的4家中國企業獲得了該授權,其中公司是在新加坡市場率先獲批核酸檢測試劑盒的中國企業。
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