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迪瑞醫療(300396.SZ)獲得醫療器械註冊證暨醫療器械註冊證變更
格隆匯 01-28 18:16

格隆匯 1 月 28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5項《醫療器械註冊證》、5項《醫療器械註冊變更文件》及國家藥品監督管理局頒發的1項《醫療器械註冊變更文件》。產品名稱分別為維生素B12測定試劑盒(化學發光免疫分析法)、鈉測定試劑盒(半乳糖苷酶法)、抗凝血酶Ⅲ測定試劑盒(髮色底物法)、遊離β人絨毛膜促性腺激素測定試劑盒(化學發光免疫分析法)、無機磷測定試劑盒(磷鉬酸鹽法)、α1-微球蛋白測定試劑盒(膠乳免疫比濁法)、全自動五分類血細胞分析儀、全自動血細胞分析儀、β2-微球蛋白測定試劑盒(膠乳免疫比濁法)、尿液分析試紙條、糖類抗原50測定試劑盒(化學發光免疫分析法)。

此次新取得的註冊產品涉及IVD行業中化學發光免疫分析及生化診斷分析。化學發光免疫分析應用涵蓋多個病種,包括腫瘤、甲功、激素、傳染病、心肌標誌物等。生化診斷是最早實現自動化的檢測手段。目前醫療衞生機構是消費生化試劑產品的主力軍。

上述《醫療器械註冊證》的取得和變更,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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