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邁克生物(300463.SZ):3項新產品取得產品註冊證書
格隆匯 06-01 18:58

格隆匯6月1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》,具體情況為:

1.轉鐵蛋白測定試劑盒(免疫比濁法),本品用於體外定量測定人血清或血漿樣本中轉鐵蛋白的含量。2.皮質醇測定試劑盒(直接化學發光法),本品用於體外定量測定人血清或血漿樣本中的皮質醇的濃度。3.總IgE測定試劑盒(直接化學發光法),本品用於體外定量測定人血清或血漿樣本中總IgE的濃度。

轉鐵蛋白測定試劑盒(免疫比濁法)主要用於診斷缺鐵性貧血,系公司生化平台新產品;皮質醇測定試劑盒(直接化學發光法)主要用於輔助診斷阿狄森氏病、庫欣綜合徵、垂體功能減退症、腎上腺增生,總IgE測定試劑盒(直接化學發光法)主要用於判斷人體是否存在過敏反應,兩款試劑盒均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66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i3000與i1000的檢測項目。

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