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基蛋生物(603387.SH):7項醫療器械註冊證完成變更登記 涉增加生產地址
格隆匯 05-20 16:55

格隆匯5月20日丨基蛋生物(603387.SH)公佈,公司於近日收到國家藥品監督管理局頒發的《醫療器械註冊變更文件(體外診斷試劑)》,此次變更主要涉及增加生產地址,產品名稱包括癌胚抗原檢測試劑盒(化學發光免疫分析法);細胞角蛋白19片段檢測試劑盒(化學發光免疫分析法);糖類抗原19-9檢測試劑盒(化學發光免疫分析法);糖類抗原50檢測試劑盒(化學發光免疫分析法);癌抗原125檢測試劑盒(化學發光免疫分析法);神經元特異性烯醇化酶檢測試劑盒(化學發光免疫分析法);癌抗原15-3檢測試劑盒(化學發光免疫分析法)。

變更內容為:新增生產地址:“南京市六合區沿江工業開發區博富路9號”變更為“南京市六合區沿江工業開發區博富路9號、南京市江北新區科豐路6號”。

上述醫療器械註冊證變更後,有利於公司合理配置產線規劃,更好的滿足市場需求,對公司近期營業收入不會產生重大影響。

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