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瑞基因(000710.SZ)胎兒染色體非整倍體檢測試劑盒完成延續註冊
格隆匯 08-16 08:34

格隆匯8月16日丨瑞基因(000710.SZ)宣佈,公司全資子公司杭州貝瑞和康基因診斷技術有限公司於近日收到國家藥品監督管理局頒發的《醫療器械註冊證》(體外診斷試劑)。

產品名稱:胎兒染色體非整倍體(T13/T18/T21)檢測試劑盒(可逆末端終止測序法);註冊證編號:國械注準20153400461;註冊證有效期:2019年8月6日至2024年8月5日;註冊分類:III類;預期用於定性檢測孕周在12周至24周的高危單胎孕婦外周血血漿中游離脱氧核糖核酸(DNA),構建測序文庫。通過分析樣本中胎兒遊離DNA的21號、18號及13號染色體數量的差異,對胎兒染色體非整倍體疾病21-三體綜合徵、18-三體綜合徵和13-三體綜合徵進行產前輔助判斷。

此次完成延續註冊的醫療器械產品為公司主要收入來源,此次醫療器械註冊證的獲得使公司可以繼續生產及銷售上述產品,保證了公司基因檢測相關產品線收入的持續性,延續了公司在基因檢測領域的持續競爭力,對公司未來經營將產生積極影響。

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