適應症
微粒子酵素免疫分析法定性測試人類血清或血漿中之anti-HBs  
劑型
 
包裝
100 Tests/Kit 
許可證字號
衛部藥製字第012068號 
註銷狀態
註銷日期
2019-11-18  
註銷理由
851 
有效日期
2017-01-03  
發證日期
2005-08-12  
許可證種類
09 
中文品名
AxSYM B型肝炎表面抗原之抗體檢驗試劑 
英文品名
AxSYM AUSAB 
藥品類別
B 血液學及病理學用裝置 
申請商地址
台北市中山區民生東路三段49號5樓、6樓及51號6樓 
通關簽審文件編號
DHA00601206800 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ABBOTT GMBH & CO.KG MAX-PLANCK-RING 2,65205 WIESBADEN,GERMANY DE
成份表
處方標示 成分名稱 含量 單位
1 AxSYM AUSAB reagent Pack*1 Bottle (3.5 ml) Hepatitis B Surface Antigen (Recombinant)(Subtypes ad and ay) Coated Microparticles Minimum concentration:0.05%, 1 Bottle (13.6 ml) Anti-Biotin(Rabbit): Alkaline Phosphatase Conjugate. Minimum concentration: 0.05 ug/ml, 1 Bottle (13.5 ml) Hepatitis B Surface Antigen (Recombinant)(Subtypes ad and ay): Biotin Conjugate. Minimum concentration: 1 ug/ml, 1 Bottle(31.4 ml) Dilution Reagent. Recalcified human plasma, AxSYM AUSAB Standard Calibrator Six bottles (4 ml each) of Standard Calibrators are prepared with recalcified human plasma, AxSYM AUSAB Controls Two bottles (8 ml each) of Controls are prepared with recalcified human plasma, AxSYM AUSAB Dilution Reagent 1 bottle (100ml) AxSYM AUSAB Dilution Reagent are prepared with recalcified human plasma, AxSYM Probe Cleaning Solution 4 bottles (110ml each) containing 2% TEAH, Solution 1 (MUP) 4 bottles (230 ml each) containing 1.2 mM 4-Methylumbelliferyl Phosphate, Solution 3 (Matrix Cell Wash) 4 bottles (1000 ml each) containing 0.3M NaCl in Tris buffer, Solution 4 (10L) containing 0.1M Phosphate Buffer