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邁克生物(300463.SZ):生長分化因子-15測定試劑盒(直接化學發光法)取得產品註冊證書
格隆匯 01-04 11:49

格隆匯1月4日丨邁克生物(300463.SZ)公佈,公司於近日收到四川省藥品監督管理局頒發的《醫療器械註冊證》。產品名稱:生長分化因子-15測定試劑盒(直接化學發光法);註冊類別:Ⅱ;預期用途:用於體外定量測定人血清或血漿中生長分化因子-15(GDF-15)的濃度。

生長分化因子-15測定試劑盒(直接化學發光法)主要用於心力衰竭的輔助診斷,系公司吖啶酯直接化學發光技術平台新產品,截至目前公司在該技術平台下已累計取得82項試劑類產品註冊(涵蓋甲狀腺功能、傳染病、心肌、腫瘤標誌物、貧血、炎症、自身免疫性疾病、生殖激素、骨代謝等病種檢測),為配套公司全自動化學發光免疫分析儀i 3000系列、i 1000系列與i 800系列的檢測項目。

該產品是國內首個基於化學發光檢測原理的生長分化因子-15獲證試劑,且通過了四川省第二類創新醫療器械特別審批,其取得註冊證不僅體現了公司的研發實力和技術儲備,也進一步豐富了公司產品項目菜單,有助於提升公司市場綜合競爭力,對市場的拓展以及公司未來的經營將產生積極影響。

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