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新產業(300832.SZ)獲得7項醫療器械註冊證
格隆匯 04-21 16:24

格隆匯4月21日丨新產業(300832.SZ)宣佈,近日,公司收到了國家藥監局頒發的7項《醫療器械註冊證》。產品名稱分別為糖類抗原72-4測定試劑盒(化學發光免疫分析法)、甲胎蛋白測定試劑盒(化學發光免疫分析法)、糖類抗原15-3測定試劑盒(化學發光免疫分析法)、糖類抗原125測定試劑盒(化學發光免疫分析法)、細胞角蛋白19片段測定試劑盒(化學發光免疫分析法)、乙型肝炎病毒核心抗體測定試劑盒(化學發光免疫分析法)、癌胚抗原測定試劑盒(化學發光免疫分析法);註冊分類均為Ⅲ類。

截至目前,公司已先後取得137項化學發光試劑《醫療器械註冊證》(共148個註冊證)。以上試劑新產品醫療器械註冊證的取得,豐富了公司化學發光檢測產品中“腫瘤標誌物”“傳染病”項目類別,將對公司發展具有正面影響。

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