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)通過日本PMDA認證
格隆匯4月1日丨華大基因(300676.SZ)公佈,公司全資子公司華大生物科技(武漢)有限公司生產製造的新型冠狀病毒核酸檢測產品於近日取得了由日本PMDA(中文譯名:日本獨立行政法人醫藥品醫療器械綜合機構)簽發的《體外診斷產品生產銷售承認書》(即日本PMDA認證)。
產品名稱:新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)(中文名);預期用途:本試劑盒適用於新型冠狀病毒感染的肺炎疑似患者或其他需要進行新型冠狀病毒感染診斷或鑑別診斷者,通過檢測從受檢者採集的上呼吸道樣本(咽拭子)或下呼吸道樣本(肺泡灌洗液)中提取的核酸以確定受檢者是否有新型冠狀病毒感染。
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。
此次公司產品通過日本PMDA認證,標誌着公司自主研發的新型冠狀病毒核酸檢測試劑盒產品具備了向日本市場供應的資質,為公司開拓日本市場打開了准入通道,有利於進一步提升公司產品的國際競爭力,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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