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基蛋生物(603387.SH):6項醫療器械產品延續註冊及完成3項醫療器械註冊證變更登記
格隆匯 08-10 17:03

格隆匯 8 月 10日丨基蛋生物(603387.SH)公佈,公司於近日收到由江蘇省藥品監督管理局頒發的6項《醫療器械註冊證(體外診斷試劑)》,以下產品延續註冊,產品名稱為抗鏈球菌溶血素O檢測試劑盒(膠乳增強免疫比濁法);視黃醇結合蛋白檢測試劑盒(膠乳增強免疫比濁法);糖化血紅蛋白檢測試劑盒(膠乳增強免疫比濁法);肌紅蛋白檢測試劑盒(膠乳增強免疫比濁法);超敏C反應蛋白檢測試劑盒(膠乳增強免疫比濁法);D-二聚體檢測試劑盒(膠體金法)。

公司於近日收到江蘇省藥品監督管理局頒發的3項《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/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),變更內容為1、檢測條件、陽性判斷值或參考區間變化;2、修改產品技術要求,但不降低產品有效性變化。3、説明書和/或產品技術要求中文字的修改,但不涉及技術內容的變更。

上述《醫療器械註冊證》的延續註冊,將能保障產品的持續銷售,延續了公司在體外診斷領域的持續競爭力,對公司未來經營將產生積極影響。產品的實際銷售情況取決於未來市場推廣效果,公司尚無法預測其對公司未來業績的影響。敬請廣大投資者予以關注並注意投資風險。

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