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微泰醫療-B(02235.HK):IVocare多功能即時檢驗產品獲得商業化資格
格隆匯 12-02 21:19

格隆匯12月2日丨微泰醫療-B(02235.HK)宣佈,公司近期獲得浙江省藥監局頒發的《糖化血紅蛋白檢測試劑盒(熒光免疫層析法)》醫療器械註冊證、《尿微量白蛋白檢測試劑盒(熒光免疫層析法)》醫療器械註冊證、《全程C反應蛋白檢測試劑盒(熒光免疫層析法)》醫療器械註冊證以及《熒光免疫分析儀》醫療器械註冊證(統稱,("醫療器械註冊證"))。至此,公司已取得IVocare多功能即時檢驗產品進行商業化所需的醫療器械註冊證。

該產品是公司自主研發的一款與糖尿病檢測相關的產品,包含測試糖化血紅蛋白、尿微量白蛋白和全程C反應蛋白所用的三種體外診斷試劑及配套使用的螢光免疫分析儀,具有體積小、操作簡單及快速定量等優點。其中:(1)糖化血紅蛋白檢測試劑盒用於體外定量檢測人全血中的糖化血紅蛋白(HbA1C)的百分比含量;(2)尿微量白蛋白檢測試劑盒用於體外定量檢測人體尿液中微量白蛋白(ALB)的含量;及(3)全程C反應蛋白檢測試劑盒用於體外定量檢測人血清、血漿或全血中C反應蛋白(CRP)的含量。該產品將在糖尿病輔助診斷、監測及治療中發揮重要作用。

公司迅速取得該產品的醫療器械註冊證,體現了公司在糖尿病監測、治療和管理領域強大的獨立研發能力,同時也豐富了我們在該領域的多樣化產品組合。公司將繼續聚焦在全球範圍內推動糖尿病監測、治療和管理方式的發展。

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