凱普生物(300639.SZ):新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)被列入WHO應急使用清單
格隆匯 6 月 17日丨凱普生物(300639.SZ)公佈,公司全資子公司潮州凱普生物化學有限公司(“凱普化學”)近日收到世界衞生組織(英文全稱“World Health Organization”,“WHO”)的通知,獲悉凱普化學研發的新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)(英文全稱“COVID-19Real-Time PCR Kit”)於2020年6月15日被列入WHO應急使用清單(英文全稱“Emergency Use Listing”,“EUL”),可供其他國家和地區採購。如無特殊情況,該產品的可供採購期限為1年。
公司將持續按照WHO法規和指南滿足WHO EUL項目的要求。若不能滿足相關條件,則產品可能面臨WHO的矯正措施,包括但不限於從WHO體外診斷程序合格產品清單中除名。
上述產品被列入WHO應急使用清單,具有一定的有效期限和相應要求。鑑於新型冠狀病毒疫情發展、產品的非唯一性以及同類產品競爭等不確定因素的影響,此次事項對公司未來業績的影響目前尚無法估計,請廣大投資者注意投資風險。
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