基蛋生物(603387.SH):取得3項醫療器械註冊證
格隆匯 2 月 23日丨基蛋生物(603387.SH)公佈,公司於近日收到了分別由國家藥品監督管理局和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)》,產品名稱分別為糖類抗原242檢測試劑盒(化學發光免疫分析法)、促黃體生成素檢測試劑盒(乾式免疫熒光法)、白細胞介素-6檢測試劑盒(化學發光免疫分析法)。
截至2020年12月31日,糖類抗原242檢測試劑盒(化學發光免疫分析法)累計已發生的研發投入約為115.53萬元、促黃體生成素檢測試劑盒(乾式免疫熒光法)累計已發生的研發投入約為53.66萬元、白細胞介素-6檢測試劑盒(化學發光免疫分析法)已發生的研發投入約為126.02萬元。
根據國家藥品監督管理局官網數據查詢信息:截至公吿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。糖類抗原242檢測試劑盒國內註冊證22個,進口註冊證2個;促黃體生成素檢測試劑盒國內註冊證48個,進口註冊證5個;白細胞介素-6檢測試劑盒國內註冊證85個,進口註冊證10個。
上述註冊證的取得,進一步豐富公司產品線,不斷滿足市場需求,是對公司現有產品的有效補充,有利於提高公司的核心競爭力,對公司未來發展具有積極作用,但近期對業績不會產生重大影響。
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