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海利生物(603718.SH):子公司抗原檢測試劑產品獲得CE准入資質
格隆匯 03-19 17:08

格隆匯 3 月 19日丨海利生物(603718.SH)公佈,公司全資子公司捷門生物近日收到歐盟公吿機構CMC MEDICAL DEVICES & DRUGS SL頒發的CE符合性聲明報吿,表明捷門生物的新冠抗原檢測試劑盒(膠體金法)【SARSCoV-2 Atigen Test Kit (Colloidal Gold)】已具備歐盟市場的准入條件。

捷門生物此次獲得CE准入的產品為抗原檢測試劑,具有檢測速度快、便於操作、無需額外檢測儀器的特點,但抗原檢測僅能作為初篩或者核酸的補充檢測手段,不能作為確診依據。

根據歐盟《98/79/EC體外診斷醫療器材指令》的規定,捷門生物在取得上述備案並出具《CE符合標準聲明》後,即表明上述產品符合歐盟相關指令要求,已經具備歐盟市場的准入條件,可以在相關海外市場合法銷售,有利於滿足國際市場客户多樣化的臨牀需求,進一步增強捷門生物產品的綜合競爭力,在全球範圍內助力新型冠狀病毒感染的肺炎疫情防控工作。

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