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明德生物(002932.SZ):全自動凝血分析儀取得醫療器械註冊證
格隆匯 03-24 20:22

格隆匯3月24日丨明德生物(002932.SZ)公佈,公司全資子公司長沙明德生物科技有限公司於近日取得了由湖南省藥品監督管理局頒發的一項II類醫療器械註冊證,產品名稱為全自動凝血分析儀CL3000。

全自動凝血分析儀CL3000採用凝固法、免疫比濁法、髮色底物法,與配套試劑盒聯合使用,用於對血液進行凝血和抗凝、纖溶和抗纖溶功能的分析。本分析儀是一種可實現多人份、多項目連續檢測的體外診斷醫療設備,測試流程自動化,操作簡單,豐富實用。

CL3000屬於中型全自動凝血分析儀,具有簡單便捷的操作體驗,原始管直接上機,軌道自動連續進樣。外置式獨立急診位,方便急診樣本更快檢測。全中文觸屏一體機,一鍵啟動自動維護和保養。反應杯可隨機倒入,自動理杯。蓋帽穿刺,提高生物安全性。

全自動凝血分析儀CL3000系公司凝血產品線首款獲證產品,豐富了公司的體外診斷產品線,提高了公司的核心競爭力和市場拓展能力,預計將對公司未來的經營成果產生正面影響。上述產品的實際銷售情況受等多因素影響,公司目前尚無法預測上述產品對公司未來營業收入的具體影響。

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