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萬孚生物(300482.SZ):取得2項產品註冊證書
格隆匯 03-15 18:40

格隆匯3月15日丨萬孚生物(300482.SZ)公佈,公司於近日正式取得國家藥品監督管理局、廣東省藥品監督管理局頒發的產品註冊證書,具體情況如下:

1.全自動核酸擴增分析系統,預期用途:本產品基於聚合酶鏈式反應(PCR)技術原理,與配套的檢測試劑共同使用,在臨牀上用於對來源於人體的口咽拭子、鼻咽拭子、痰液、骨髓、FFPE樣本中的靶核酸(DNA/RNA)進行定性檢測,包括病原體、腫瘤相關基因突變、耐藥基因突變檢測項目;

2.血栓彈力圖儀,預期用途:本產品與配套試劑使用,用於對血液進行凝血和抗凝、纖溶和抗纖溶功能的分析。

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