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三諾生物(300298.SZ):公司產品簽署歐盟CE符合性聲明暨取得醫療器械註冊證
格隆匯 12-28 20:18

格隆匯 12 月 28日丨三諾生物(300298.SZ)公佈,近日,公司產品新型冠狀病毒(SARS-CoV-2)抗原檢測試劑盒(膠體金法)通知歐盟主管當局完成產品自我宣表明該產品符合歐盟相關要求,具備歐盟市場準入條件

上述新型冠狀病毒抗原檢測試劑盒運用膠體金免疫層析技術,利用抗原抗體的特異性結合原理,配合膠體金標記物顯色,實現對人體鼻咽拭子樣本中的新型冠狀病毒抗原N蛋白的體外定性檢測新型冠狀病毒抗原檢測可作為新型冠狀病毒感染的輔助診斷。

目前上述產品未取得中國醫療器械產品註冊證書,產品出口銷售還需申請列入白名單,上述產品正在申德國備案號階段,取得德國備案號即可列入白名單因此,上述產品暫時不能出口,也不能在國內銷售,不會對公司的業績產生影響。

近日,公司取得由湖南省藥品監督管理頒發的項《醫療器械註冊證》,體情況如下:

次醫療器械註冊證的取得,進一步豐富和延續了公司產品的品類和規格,有助於滿足市場多樣化的檢測需求。尿酸質控液《醫療器械註冊證》為原註冊證20162400130的延續註冊上述醫療器械註冊證涉及的相關產品實際銷售情況取決於未來市場的推廣效果,對上市公司未來經營業績的影響存在不確定性。

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