美康生物(300439.SZ):6項產品取得醫療器械註冊證
格隆匯11月12日丨美康生物(300439.SZ)公佈,近日,公司6項產品取得了由浙江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(體外診斷試劑)》。6項產品分別為:
糖類抗原15-3檢測試劑盒,用於人血清中糖類抗原15-3濃度的體外定量測定。不能作為惡性腫瘤早期診斷或確診的依據,不用於普通人羣的腫瘤篩查;
全段甲狀旁腺激素檢測試劑盒,用於人血清中全段甲狀旁腺激素濃度的體外定量測定;
腎素檢測試劑盒,用於人EDTA血漿中腎素濃度的體外定量測定;
皮質醇檢測試劑盒,用於人血清或EDTA血漿中皮質醇濃度的體外定量測定;
糖類抗原125檢測試劑盒,用於人血清中糖類抗原125濃度的體外定量測定。不能作為惡性腫瘤早期診斷或確診的依據,不用於普通人羣的腫瘤篩查;
糖類抗原19-9檢測試劑盒,用於人血清中糖類抗原19-9濃度的體外定量測定。不能作為惡性腫瘤早期診斷或確診的依據,不用於普通人羣的腫瘤篩查。
截至本公吿出具日,公司已取得 53個化學發光類試劑《註冊證》。上述《註冊證》的取得,延續了公司在化學發光類產品線的品種,有利於進一步提升公司的核心競爭力和市場拓展能力,對公司未來的經營將產生積極影響。
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