適應症
定量檢測人體血清、血漿、及尿液中濾泡刺激素FSH之含量。  
劑型
 
包裝
#13101: 150 Tubes, #13102: 300 Tubes, 以下空白。 
許可證字號
衛部藥製字第015115號 
註銷狀態
註銷日期
2018-05-28  
註銷理由
838 
有效日期
2015-11-30  
發證日期
2005-11-30  
許可證種類
09 
中文品名
"鐳定" 濾泡刺激素放射免疫分析試劑 
英文品名
"RADIM" FSH MAIAclone 
藥品類別
A 臨床化學及臨床毒理學 
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
DHAS0601511503 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
RADIM S.P.A. VIA DEL MARE, 125, 00040 POMEZIA (ROMA), ITALIA IT
成份表
處方標示 成分名稱 含量 單位
1 1. I-125 Anti-FSH Reagent (Red): 3 (or 6) vials, 5.4 ml per vial, containing fluorescein and iodine-125 labelled mouse monoclonal antibodies to FSH, <370 kBq per vial, in phosphate buffer containing normal sheep serum, bovine serum albumin (BSA), inert dye and sodium azide 0.2%, w/v.\n\n2. FSH MAIAclone Calibrator 0 mIU/ml: 3.0 ml per vial, containing bovine serum with sodium azide, 0.2% w/v.\n\n FSH MAIAclone Calibrators 0.5- 2- 10- 25- 75 and 150 mIU/ml: 1.0 ml per vial, precalibrated at 0.5- 2- 10- 25- 75 and 150 mIU/ml of FSH per ml (2nd IRP 78/549) in bovine serum with sodium azide, 0.2% w/v.\n\n3. FSH MAIAclone Separation Reagent: 1 vial (33.0 ml), containing sheep antiserum to fluorescein covalently bound to magnetic particles in Tris buffer with BSA and sodium azide, 0.1% w/v. \n\n4. MAIAclone Wash Buffer Concentrate: 1 vial (12.5 ml), containing Tris buffer and sodium azide, 0.8% w/v. Before use dilute the contents of the vial to a total volume of 100 ml with distilled or deionised wat