貝瑞基因(000710.SZ):“染色體拷貝數變異檢測試劑盒(可逆末端終止測序法)”醫療器械註冊申請獲受理
格隆匯5月28日丨貝瑞基因(000710.SZ)公佈,公司全資子公司杭州貝瑞和康基因診斷技術有限公司於近日收到國家藥品監督管理局頒發的《受理通知書》,“染色體拷貝數變異檢測試劑盒(可逆末端終止測序法)”醫療器械注冊申請獲得受理。
該試劑盒較傳統的染色體畸變檢測技術,可精準、全面、高效、經濟地獲得染色體拷貝數檢測結果,供臨牀參考使用。未來該試劑盒若獲批上市,將進一步豐富公司生育健康領域的產品管線,提高公司產品模式的市場競爭力,將對公司未來經營產生積極影響。
根據國家相關注冊法規規定,此次申報註冊獲得受理後,將由國家藥品監督管理局依法進行評審方能獲得醫療器械註冊證,後續相關審評工作所需的時間和結果均具有一定的不確定性,因此,公司尚無法預測其對公司未來業績的影響,公司將根據本次申報註冊的進展情況及時按規定履行信息披露義務。敬請廣大投資者謹慎決策,注意投資風險。
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