東方生物(688298.SH):獲得醫療器械註冊證
格隆匯12月19日丨東方生物(688298.SH)公佈,全資子公司美國衡健生物科技有限公司近日取得毒品尿杯聯合檢測試劑(專業/自測)的美國食品藥品監督管理局FDA510(K)許可證;東方生物的新冠/甲乙流抗原三聯檢試劑(專業/自測)近日取得歐盟IVDR註冊證書。本次全資子公司美國衡健的毒品尿杯聯合檢測試劑(專業/自測)獲得美國FDA510(K)認證,豐富了公司在美國市場毒品檢測試劑的產品種類,有利於公司在美國市場毒品檢測產品的市場拓展。東方生物新冠/甲乙流抗原三聯檢試劑(專業/自測)在歐盟取得IVDR證書,完善了歐盟市場呼吸道聯合檢測產品的產品種類,有利於應對常態化、季節性的呼吸道疾病的檢測需求。
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