熱景生物(688068.SH):取得“新型冠狀病毒抗體檢測試劑盒”醫療器械註冊證
格隆匯5月25日丨熱景生物(688068.SH)公告,公司於2020年5月25日收到國家藥品監督管理局(以下簡稱:“NMPA”)頒發的《醫療器械註冊證》。
產品名稱:新型冠狀病毒(2019-nCoV)抗體檢測試劑盒(上轉發光免疫層析法)
預期用途:本試劑盒用於體外定性檢測人血清或血漿樣本中的新型冠狀病毒抗體。僅用作對新型冠狀病毒核酸檢測陰性疑似病例的補充檢測指標或疑似病例診斷中與核酸檢測協同使用,不能作為新型冠狀病毒感染的肺炎確診和排除的依據,不適用於一般人羣的篩查。本產品僅限醫療機構使用。
上述醫療器械註冊證的取得,豐富了公司產品種類,將增強公司綜合競爭力,有利於進一步提高公司的市場拓展能力。根據NMPA官方數據查詢信息,截至本公告披露日,國內已有約13個廠家取得新型冠狀病毒抗體檢測產品註冊證書。
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