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華大基因(300676.SZ):子公司13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 08-05 20:39

格隆匯8月5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)的十三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:

上述十三項檢測試劑盒主要於腫瘤篩查防控相關的檢測產品,是基於管式的磁微粒平台的獲證產品,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,華大吉比愛已有項基於磁分離技術的磁微粒即時檢測(POCT)平台的檢測試劑三十餘項基於板式的化學發光平台的檢測試劑十餘項基於管式的磁微粒化學發光平台的檢測試劑產品本次十三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,可滿足客户多樣化的需求

上述十三項產品取得醫療器械註冊證,標誌着該產品多項檢測項目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進一步豐富了公司的產品。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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