新產業(300832.SZ):新型冠狀病毒檢測產品等取得CE准入資格
格隆匯 2 月 21日丨新產業(300832.SZ)公佈,近日,公司收到了SARS-CoV-2 Ag (CLIA)、SARS-CoV-2, Flu & RSV RT-PCR Assay及Nucleic Acid Extraction Kit三項產品的德國註冊提交憑證。

上述三項產品已完成歐盟准入的所有流程,能夠加貼CE標誌進入歐盟市場,將進一步豐富公司新冠病毒檢測產品類型,增強公司新冠病毒檢測產品的綜合競爭力,滿足多種應用場景的臨牀需求。
上述取得歐盟CE准入資格的新冠病毒檢測產品還需進入中國醫藥保健品進出口商會發布的《取得國外標準認證或註冊的醫療物資生產企業清單》方可在歐盟市場開展銷售,公司已獲得新冠病毒抗體檢測試劑出口資質,將在此基礎上儘快開展申報,具體可在歐盟開展銷售時間暫無法確定。上述產品可開展銷售後的銷售情況取決於歐盟市場對新冠病毒檢測的需求量及公司在歐盟市場拓展情況,公司目前尚無法預測其對公司未來業績的影響。
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