科華生物(002022.SZ):SMN1檢測試劑盒獲醫療器械註冊證
格隆匯11月25日丨科華生物(002022.SZ)公佈,近日,公司控股子公司蘇州天隆生物科技有限公司收到國家藥監局頒發的《醫療器械註冊證》(體外診斷試劑)。產品名稱:人運動神經元存活基因1(SMN1)檢測試劑盒(PCR-熔解曲線法);註冊證有效期:2021年11月12日-2026年11月11日。
該產品適用於體外定性檢測人EDTA抗凝全血樣本人基因組DNA中運動神經元存貨基因SMN1基因第7外顯子和/或第8外顯子的拷貝數。
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