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華大基因(300676.SZ):四項基於磁微粒化學發光法檢測試劑盒取得醫療器械註冊證
格隆匯 05-06 22:13

格隆匯 5 月 6日丨華大基因(300676.SZ)公佈,公司控股子公司北京華大吉比愛生物技術有限公司(以下簡稱華大吉比愛)的四項基於磁微粒化學發光法檢測試劑盒於近日取得了北京市藥品監督管理局頒發的醫療器械註冊證,具體情況如下:

上述4項檢測試劑盒華大吉比愛基於管式的磁微粒平台的首批獲證產品聯合公司全自動化學發光免疫分析儀使用,臨牀上用於定量測定人血清或血漿中相關腫瘤標誌物的含量,可以為腫瘤的篩查與診斷、用藥指導、復發監測等提供參考。

磁微粒化學發光法具有靈敏度高、檢測結果穩定、磁性分離技術的快速易自動化、操作簡便等優點,是目前較為先進的標記免疫測定技術之一。截至目前華大吉比愛已有10基於磁分離技術的磁微粒即時檢測(POCT)平台檢測試劑30基於板式的化學發光平台檢測試劑獲證本次基於管式的磁微粒化學發光平台產品獲證豐富了公司化學發光類平台產品系列可滿足客户個性化的需求。

上述4項產品取得醫療器械註冊證,標誌着該產品具備了獲批上市的資質,是對公司現有檢測產品的有效補充不斷滿足市場需求,增強了公司產品的整體競爭力。上述產品實際銷售情況取決於市場實際需求及未來市場推廣效果等因素的影響。公司目前尚無法預測其對公司未來業績的影響,敬請投資者注意投資風險。

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