東方生物(688298.SH):獲得醫療器械註冊證
格隆匯7月4日丨東方生物(688298.SH)公佈,浙江東方基因生物製品股份有限公司及子公司美國衡健生物科技有限公司(以下簡稱“東方生物”“美國衡健”或合稱“公司”)部分合作客戶於近期取得以下幾款呼吸道聯檢產品的境外醫療器械註冊證書或生產銷售許可書;控股子公司北京新興四寰生物技術有限公司完成一項產品的變更註冊(備案)。
公司呼吸道抗原聯合檢測試劑(自測/專業)在上述國家和地區獲得註冊,表明上述產品已符合相關國家和地區要求,具備了該市場的準入條件。
幽門螺旋桿菌抗原檢測試劑的三類註冊證變更主要增加了自測用途及延長了產品的有效期,在原有銷售的基礎上進一步增加了可銷售客戶羣體的範圍。
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