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海利生物(603718.SH):捷門生物新冠病毒中和抗體檢測試劑盒獲CE准入資質
格隆匯 04-06 18:17

格隆匯4月6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CMCMEDICALDEVICES&DRUGSSL頒發的CE符合性聲明報吿,表明捷門生物的新型冠狀病毒中和抗體檢測試劑盒(熒光免疫層析法)已具備歐盟市場的准入條件。

捷門生物本次獲得的CE准入產品為新型冠狀病毒中和抗體檢測試劑,具有檢測方便、測試速度快、靈敏度高的特點,但中和抗體檢測易受抑制性多肽和小分子抑制劑等影響,故只能作為輔助檢測手段,不能作為評價標準。

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