科華生物(002022.SZ):公司產品被列入WHO應急使用清單
格隆匯6月8日丨科華生物(002022.SZ)宣佈,公司今日收到WHO通知,公司的產品“SARS-CoV-2 Nucleic Acid Test (Real-time PCR)”【中文名稱:新型冠狀病毒(2019-nCoV)ORF1ab/N/E基因核酸檢測試劑盒(熒光PCR法)】,於2020年6月5日被列入為WHO應急使用清單(簡稱“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應急使用清單合格體外診斷產品中除名。
公司表示,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。
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