碩世生物(688399.SH):新冠病毒測試劑盒獲德國聯邦藥品和醫療器械研究所(BfArM)認證
格隆匯7月13日丨碩世生物(688399.SH)公吿,公司於近日獲得德國聯邦藥品和醫療器械研究所(BfArM)特別批准新型冠狀病毒抗原檢測試劑一項。該產品名為“新型冠狀病毒(SARS-CoV-2)抗原快速檢測試劑盒(自檢)”。
公司以上產品獲得德國聯邦藥品和醫療器械研究所(BfArM)特殊批准後,具備了德國和認可德國BfArM認證的國家及地區進行銷售的准入資質,符合上述地區授權認證要求和新冠疫情不斷變化的檢測需求。上述產品暫未在上述地區產生收入,但取得上述批准有利於提高公司的市場拓展能力,尤其是對國際業務拓展具有積極的作用。
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