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迪瑞醫療(300396.SZ):申報的4項醫療器械註冊獲得受理
格隆匯 04-08 22:44

格隆匯 4 月 8日丨迪瑞醫療(300396.SZ)公佈,公司於近日取得由吉林省藥品監督管理局頒發的4項《受理通知書》,具體情況如下:

上述受理的產品涉及化學發光免疫分析、婦科分析及生化分析領域,化學發光免疫分析是體外診斷行業最重要的細分項目之一,公司化學發光產品可以進行甲狀腺功能、傳染病、性激素、骨代謝、炎症、腫瘤標誌物、糖代謝、心肌標誌、腎功能、高血壓、肝纖維化、貧血等項目的檢測。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及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90餘項,可以滿足不同規模的終端需求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。

細菌性陰道病對婦女身體健康及妊娠可產生極大的危害性,因此對其準確診斷及其對陰道環境損害程度的判斷具有十分重要的意義。此項受理的陰道分泌物檢測儀用於檢測陰道分泌物中的幹化學成分,採用的幹化學檢測技術應用光電比色原理預計可實現9項幹化學檢測項目。公司婦科分析產品面向全球銷售,有全球領先技術。公司根據終端客户需求不斷豐富婦科分析儀器產品的種類,進一步提升產品競爭力。

生化診斷是最早實現自動化的檢測手段,也是目前最常用的體外診斷方法之一。公司現有生化分析儀器數十款,生化試劑相關產品註冊證百餘項公司將不斷提升生化與免疫相結合產品市場佔有率。

上述產品目前所處的審批階段為:註冊申請受理,後續所需的審批流程為技術審評、行政審批、制證。上述品種註冊申請受理對公司近期業績不會產生影響,審評在各階段所需的時間和結果均具有一定的不確定性,公司將對上述品種的後續進展情況及時履行信息披露義務。

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