安圖生物(603658.SH):新冠肺炎核酸檢測試劑盒獲批上市
格隆匯7月7日丨安圖生物(603658.SH)公吿,公司於近日收到國家藥品監督管理局頒發的關於新型冠狀病毒2019-nCoV核酸檢測試劑盒(PCR-熒光探針法)的《醫療器械註冊證》,註冊證有效期為5年。
該試劑盒用於體外定性檢測新型冠狀病毒肺炎疑似病例、聚集性病例、其他需要進行新型冠狀病毒感染診斷或鑑別診斷者的口咽拭子和痰液樣本中,新型冠狀病毒(2019-nCoV)ORF1ab和N基因。
上述註冊證的取得,將加速公司在分子診斷領域佈局,不斷滿足多元化的市場需求,可以逐步提高公司產品的整體競爭力。
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