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迪瑞醫療(300396.SZ):取得1項醫療器械註冊證
格隆匯 07-27 20:05

格隆匯7月27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1醫療器械註冊證具體情況如下:

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,公司佈局化學發光免疫產業多年,目前進入到收穫期,銷售渠道佈局正在逐步完善當中。公司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、心肌標誌物、腎功能、高血壓、肝纖維化、貧血等項目的檢測。公司新推出的異常凝血酶原測定試劑盒,是血液學診療肝癌的標誌物之一,用於肝癌早期的輔助判斷及療效評價,與甲胎蛋白測定試劑盒聯合使用可提高肝癌檢測的靈敏度和特異度。此項產品的獲准上市,是繼甲胎蛋白測定試劑盒後的又一突破,標志着公司在肝癌檢測方面更加完善。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,助力公司快速發展。

上述產品的取得,豐富了公司產品種類,將進一步增強公司產品的綜合競爭力,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對公司未來業績的影響。

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