艾德生物(300685.SZ):收到醫療器械變更註冊文件
格隆匯2月20日丨艾德生物(300685.SZ)公佈,公司於近日收到由國家藥品監督管理局頒發的《醫療器械變更註冊文件》,公司已完成“PD-L1抗體試劑(免疫組織化學法)”產品原註冊證相關事項的變更。
變更內容:預期用途增加“本試劑盒用於體外定性檢測經10%中性緩衝福爾馬林固定石蠟包埋(FFPE)胃/胃食管交界處腺癌(Gastric Adenocarcinoma/Gastroesophageal Adenocarcinoma,GA/GEA)組織切片中PD-L1蛋白的表達情況,輔助鑑別可使用舒格利單抗聯合化療治療的GA/GEA患者,用作舒格利單抗聯合化療的伴隨診斷。”。
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