適應症
用來檢測人體血清、血漿、羊水檢體中甲胎兒蛋白的含量。  
劑型
 
包裝
#14764:120 tubes 
許可證字號
衛部藥製字第016305號 
註銷狀態
註銷日期
2012-11-27  
註銷理由
838 
有效日期
2011-04-04  
發證日期
2006-04-04  
許可證種類
09 
中文品名
"亞斯特" 甲胎兒蛋白放射免疫分析試劑 
英文品名
"Adaltis" AFP Bridge 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
台北市大同區承德路二段81號15樓 
通關簽審文件編號
DHAS0601630500 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ADALTIS ITALIA S.P.A. VIA CRISTONI, 12, 40033 CASALECCHIO DI RENO, BOLOGNA (BO), ITALY IT
成份表
處方標示 成分名稱 含量 單位
1 1. AFP Bridge Coated Tubes: 120 tubes. Each carton box contains 60 tubes packed in a plastic bag. Each tube is coated with mouse monoclonal antibody to AFP.\n\n2. AFP Bridge Tracer: 2 vials. Each vial contains I-125 labeled mouse monoclonal antibody to human AFP. Maximum radioactivity 424 kBq per vial. Each vial contains phosphate buffer with bovine, horse, sheep and mouse serum and sodium azide, <0.1% w/w. 63 ml per vial.\n\n3. AFP Bridge Calibrators: 6 vials. The vials contain respectively: 0- 2- 10- 50- 200 and 500 IU (0 - 2.42-12.1- 60.5- 242 and 605 ng) of AFP per ml, (1st IS 72/225) in horse serum with sodium azide, <0.1% w/w. 0.6 ml per vial.\n\n4. Coated Tube Wash Concentrate: 1 vial. The vial contains an aqueous solution of Triton x-100, 8 ml. Add the contents of the vial to 1000 ml of distilled or deionized water.\n\n5. Serotest P: 1 vial. The vial contains lyophilized human serum with sodium azide, <0.1% w/w, 1 ml after reconstitution. Reconstitute with 1.0 ml distil