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基蛋生物(603387.SH):完成熒光免疫定量分析儀醫療器械註冊證變更登記 涉增加適用範圍
格隆匯 06-03 16:03

格隆匯6月3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》,此次變更主要涉及增加適用範圍。

產品名稱為熒光免疫定量分析儀,變更內容為增加適用範圍:變更為“熒光免疫定量分析儀配套本公司免疫熒光法的專用試劑盒,可體外定量檢測人血清、血漿、全血、末梢血或尿液中心肌肌鈣蛋白Ⅰ、N-端腦利鈉肽前體、全量程C反應蛋白(hs-CRP+常規CRP)、超敏C反應蛋白、肌紅蛋白、肌酸激酶同工酶、D-二聚體、降鈣素原、微量白蛋白、胱抑素C、β2-微球蛋白、中性粒細胞明膠酶相關脂質運載蛋白、心型脂肪酸結合蛋白、糖化血紅蛋白、絨毛膜促性腺激素及β亞單位、血清澱粉樣蛋白A的含量,檢測結果用於臨牀輔助診斷。”

上述醫療器械註冊證變更後,將進一步擴大產品適用範圍,更好的滿足市場需求,有利於提升該產品的市場競爭力,對公司近期營業收入不會產生重大影響。相關產品實際銷售情況取決於市場的推廣效果,目前尚無法預測上述產品對公司未來營業收入的影響,敬請廣大投資者注意投資風險。

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