海利生物(603718.SH):乾式時間分辨熒光分析儀獲醫療器械註冊證
格隆匯3月9日丨海利生物(603718.SH)公佈,公司全資子公司上海捷門生物技術有限公司(以下簡稱“捷門生物”)相關產品於近日收到上海市藥品監督管理局頒發的《醫療器械註冊證》。
乾式時間分辨熒光分析儀配套基於熒光免疫層析原理的乾式試劑盒使用,能夠對熒光免疫層析試劑盒中檢測卡上檢測線與質控線熒光強度進行定量分析,可以測定人體體液樣本中特定的一種或幾種蛋白的含量,以供醫護人員對患者的特定疾病或損傷做出診斷,或針對特定疾病給予患者相應預防、監護、治療等措施。該產品獲得註冊證後,無須再履行其他審評程序即可上市銷售。
捷門生物是公司全資子公司,本次完成註冊登記的儀器是捷門生物第一款POCT儀器。POCT:即時檢驗point-of-caretesting,指在病人旁邊進行的臨牀檢測及牀邊檢測,是在採樣現場即刻進行分析,省去標本在實驗室檢驗時的複雜處理程序,快速得到檢驗結果的一類新方法,具有快速、使用簡單、綜合成本低等特點。本儀器將與配套的熒光層析試劑一起使用,對於捷門生物搭建POCT平台,進入快速診斷領域具有重要意義。
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