新華醫療(600587.SH):糖化血紅蛋白分析用洗脱液獲得二類醫療器械註冊證
格隆匯12月24日丨新華醫療(600587.SH)公佈,公司於近日收到山東省藥品監督管理局頒發的《中華人民共和國醫療器械註冊證》,具體情況如下:
產品名稱:糖化血紅蛋白分析用洗脱液(高效液相色譜法);預期用途:與糖化血紅蛋白分析系統配套使用,用於體外檢測人全血中糖化血紅蛋白的含量;同類產品相關情況:根據國家藥品監督管理局官網數據查詢信息,截至目前,國內同行業有 18家公司已取得同類產品的醫療器械註冊證;產品主要特點:糖化血紅蛋白分析用洗脱液(高效液相色譜法)與糖化血紅蛋白分析儀配套使用,採用離子交換高壓液相色譜法,用於體外檢測人全血中糖化血紅蛋白的含量,是糖尿病篩選、診斷、血糖控制、療效考核的有效檢測指標,其準確度高、重複性好。
糖化血紅蛋白分析用洗脱液(高效液相色譜法)的批准上市完善了糖化血紅蛋白檢測平台,進一步豐富了公司體外診斷產品線,有助於提升公司的核心競爭力,對公司未來的經營產生積極影響。
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