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迪瑞醫療(300396.SZ):取得4項醫療器械註冊變更文件
格隆匯 09-22 16:41

格隆匯 9 月 22日丨迪瑞醫療(300396.SZ)公佈,公司於近日取得國家藥品監督管理局頒發4醫療器械註冊變更文件

化學發光免疫分析作為體外診斷行業最重要的細分項目之一,其臨牀應用涵蓋多個病種,包括腫瘤、甲功、激素、傳染病、心肌標誌物等。公司長期堅持試劑和儀器均衡發展,目前,公司化學發光免疫分析儀器相關產品有CM-180CM-320CM-320i全自動化學發光免疫分析儀CSM-8000模塊化生化免疫分析系統,化學發光免疫分析試劑相關產品註冊證擁有約80項,是國內體外診斷行業化學發光檢測項目較為齊全的廠家之一。在未來發展中,公司將繼續開發補充臨牀高價值檢驗項目,持續豐富體外診斷產品覆蓋領域,再添產業新佈局。

上述《醫療器械註冊證》的變更,豐富和延續了公司產品種類,將進一步增強公司綜合競爭力,有利於進一步提高公司的市場拓展能力,對公司未來的經營將產生積極影響。上述產品實際銷售情況取決於未來市場推廣效果,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。公司未來會積極推動相關產品在國內市場的銷售,為廣大股東創造更大的價值。

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