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艾德生物(300685.SZ):“AmoyDxPanlungcancerPCRpanel”醫療器械註冊申請在日本獲受理
格隆匯 08-20 20:29

格隆匯 8 月 20日丨艾德生物(300685.SZ)公佈,基於PCR技術平台自主研發的肺癌多基因聯合檢測產品“AmoyDxPanlungcancerPCRpanel”(即艾惠健升級版)已完成在日本的產品註冊臨牀試驗,於近日收到日本醫藥品醫療器械綜合機構(PMDA)下發的《受理通知書》。

上述醫療器械後續所需的審批流程為行政審批等。上述醫療器械註冊申請受理對公司近期業績不會產生影響,行政審批所需的時間和結果均具有一定的不確定性,公司將對上述醫療器械的後續進展情況及時履行信息披露義務。敬請廣大投資者謹慎決策,注意防範投資風險。

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