新華醫療(600587.SH):公司產品獲得二類醫療器械註冊證
格隆匯6月17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》,試劑盒用於評估人凝血及纖溶系統的功能。適用於凝血功能異常,急性創傷、休克,術前、術後以及需要輸血人羣,通過評估凝血全貌,輔助醫生判斷凝血狀態,區分原發和繼發纖溶亢進,判斷促凝和抗凝等藥物的療效,評估血栓發生機率,預防血栓發生。
血栓彈力圖活化凝血檢測試劑盒(凝固法)的批準上市,對臨牀評估凝血功能、指導成分輸血、預測血栓/出血風險以及用藥指導均具有巨大價值,豐富新華醫療體外診斷類產品,有利於提升公司的市場競爭力。
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