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⚠️ 此醫材許可證已註銷
狀態:已註銷 日期:2012/11/27
原因:許可證已逾有效期
"亞特斯" 癌胚胎抗原放射免疫分析試劑
🩺 醫材"Adaltis" CEA Bridge
衛署醫器輸字第016308號
GDP 認證供應商
醫材分類
第 2 等級
- C.6010腫瘤相關抗原免疫試驗系統
醫器規格
#14664: 120 tubes
限制項目
輸 入;;輸入須附同意書(每次輸入均須取得原子能委員會之同意書為憑)
適應症
用來檢測人體血清、血漿檢體中癌胚胎抗原(CEA)的含量。
醫材資訊
- 主成分
- 1. CEA Bridge Coated Tubes: 120 tubes; each carton box contains 60 tubes, packed in a plastic bag, coated with mouse monoclonal antibody to CEA.\n2. CEA Bridge Tracer: 1 vial/25 ml; containing lyophilized I-125 labelled mouse monoclonal antibody to human CEA. Maximum Radioactivity: 848 kBq per vial. The vial contains phosphate-citrate buffer with bovine serum albumin, sheep and mouse serum.\n3. CEA Bridge Calibrators: 5 vials; the vials contain respectively: 0, 20, 80, 320, 1280 mIU (0, 1, 4, 16, 64 ng) of CEA per ml, (1st IRP 73/601) horse serum with sodium azide \n4. Coated Tube Wash Concentrate: 1 vial containing an aqueous solution of Triton X-100 8 ml.\n5. CEA Normal Control: 1 vial containing lyophilized human serum with sodium azide <0.1%\n6. CEA Pathological Control: 1 vial containing lyophilized human serum with sodium azide <0.1%\n7. CEA Diluent: 1 vial containing horse serum and sodium azide <0.1%\n
- 製造商
- ADALTIS ITALIA S.P.A.
- 製造國
- IT
- 申請商
- 泰歷藥品儀器股份有限公司
- 有效日期
- 2011/04/06
- 發證日期
- 2006/04/06
供應藥局
目前尚無登錄供應此品項的藥局資料。