華大基因(300676.SZ):控股子公司多重PCR檢測產品獲得歐盟CE准入資質
格隆匯7月27日丨華大基因(300676.SZ)公吿,公司控股子公司深圳華大因源醫藥科技有限公司(簡稱華大因源)的總計六項感染相關的中通量核酸多重檢測試劑產品於近日獲得了歐盟CE准入資質。
PCR技術具有靈敏度高、特異性好、及時方便等優點,已經成為許多臨牀診斷的“金標準”,廣泛應用於感染性疾病病原體檢測。本次獲得歐盟CE准入資質的六項中通量核酸多重檢測試劑,分別應用於耐藥基因、中樞神經系統感染以及呼吸道感染方面的檢測,六項產品均使用了PCR技術。
根據歐盟《體外診斷醫療器械指令》規定,華大因源已經完成了上述產品的CE申報,並得到了主管機構的確認,上述產品已具備歐盟市場的准入條件。此次獲得的中通量核酸多重檢測試劑產品歐盟CE准入資質,進一步提升了公司在病原檢測方面的核心競爭力,對公司感染防控業務將產生積極影響。
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