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邁克生物(300463.SZ):6種新產品取得產品註冊證書
格隆匯 02-02 15:56

格隆匯 2 月 2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》,產品名稱分別為遊離脂肪酸測定試劑盒(ACS-ACOD法)、鐵測定試劑盒(亞鐵嗪法)、銅測定試劑盒(PAESA顯色劑法)、抗繆勒氏管激素測定試劑盒(直接化學發光法)、超敏C-反應蛋白測定試劑盒(免疫散射比濁法)、全段甲狀旁腺激素測定試劑盒(直接化學發光法)。

遊離脂肪酸測定試劑盒主要用於人體脂肪分解代謝狀態的檢測,鐵測定試劑盒主要用於貧血的輔助檢查,銅測定試劑盒主要用於銅代謝異常相關疾病的篩查,超敏C-反應蛋白測定試劑盒用於各種炎症的檢測,上述四個產品均為公司生化檢測平台的試劑新產品;抗繆勒氏管激素測定試劑盒主要用於生殖激素方面的檢測,全段甲狀旁腺激素測定試劑盒主要用於甲狀旁腺功能及血鈣代謝異常疾病的檢測,上述兩項產品系公司吖啶酯直接化學發光技術平台的新產品,截至目前公司在該技術平台下已累計取得51項試劑類產品註冊證(涵蓋甲狀腺功能、傳染病、心肌、腫瘤標誌物、貧血、炎症、自免類風濕、生殖激素、骨代謝、糖代謝等相關疾病的檢測),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。新產品取得註冊證進一步豐富了公司產品項目種類,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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