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新華醫療(600587.SH):血小板聚集功能(AA途徑)檢測試劑盒(凝固法)等3項產品獲得二類醫療器械註冊證
格隆匯 01-06 16:27

格隆匯1月6日丨新華醫療(600587.SH)公佈,公司於近日收到山東省藥品監督管理局頒發的《中華人民共和國醫療器械註冊證》,產品名稱為:血小板聚集功能(AA途徑)檢測試劑盒(凝固法)(二類醫療器械註冊證)、血小板聚集功能(ADP途徑)檢測試劑盒(凝固法)(二類醫療器械註冊證)、血小板聚集功能(ADP及AA途徑)檢測試劑盒(凝固法)(二類醫療器械註冊證)。

根據國家藥品監督管理局官網數據查詢信息,截至目前,國內同行業有16家公司已取得同類產品的醫療器械註冊證。血小板聚集功能(AA途徑)檢測試劑盒(凝固法)、血小板聚集功能(ADP途徑)檢測試劑盒(凝固法)、血小板聚集功能(ADP及AA途徑)檢測試劑盒(凝固法)與血栓彈力圖儀配套使用,體外檢測人全血的血塊強度,通過血塊強度計算抑制率,從而判斷血小板聚集功能。主要用於輔助評價冠脈心臟病、心肌梗塞等患者服用氯吡格雷或阿司匹林等藥物後血小板的聚集功能。

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