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基蛋生物(603387.SH)完成部分醫療器械註冊證變更登記及取得醫療器械註冊證
格隆匯 12-11 16:28

格隆匯12月11日丨基蛋生物(603387.SH)公佈,公司於近日收到江蘇省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)》,產品名稱為心肌肌鈣蛋白I檢測試劑盒(乾式免疫熒光法)、N-端腦利鈉肽前體檢測試劑盒(乾式免疫熒光法)、N-端腦利鈉肽前體/心肌肌鈣蛋白I二合一檢測試劑盒(乾式免疫熒光法)、肌酸激酶同工酶/心肌肌鈣蛋白I/肌紅蛋白三合一檢測試劑盒(乾式免疫熒光法)、D-二聚體檢測試劑盒(乾式免疫熒光法)、降鈣素原檢測試劑盒(乾式免疫熒光法)、降鈣素原/C反應蛋白二合一檢測試劑盒(乾式免疫熒光法)。

公司於近日收到了由江蘇省藥品監督管理局頒發的《醫療器械註冊證(體外診斷試劑)》,產品名稱為甲狀腺功能複合質控品、激素多項檢測質控品、特種蛋白質控品。

截至2019年9月30日,甲狀腺功能複合質控品累計已發生的研發投入約為39.02萬元;激素多項檢測質控品累計已發生的研發投入約為42.96萬元;特種蛋白質控品累計已發生的研發投入約為36.68萬元。

根據國家藥品監督管理局官網數據查詢信息:截止公告日國內外同行業多個廠家已取得同類產品的醫療器械註冊證書。伯樂、朗道、賽默飛、邁瑞、萬孚等具有甲狀腺功能複合質控品同類產品;奧森多、伯樂、朗道、邁瑞等具有激素多項檢測質控品同類產品;伯樂、朗道、貝克曼、安圖、邁瑞、美康、邁克等均有特種蛋白質控品同類產品。

上述註冊證變更後,將進一步擴大產品適用範圍,有利於提升該產品的市場競爭力,對公司未來的經營將產生積極影響。上述註冊證的取得,進一步豐富公司質控品產品線,不斷滿足市場需求,是對公司現有產品的有效補充,可以逐步提高公司的整體競爭力。

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