適應症
酵素免疫法測定血中B型肝炎表面抗原之抗體  
劑型
 
包裝
100 Tests/Kit 
許可證字號
衛部藥製字第011755號 
註銷狀態
註銷日期
2012-11-06  
註銷理由
838 
有效日期
2011-08-27  
發證日期
2005-08-08  
許可證種類
09 
中文品名
IMx B型肝炎表面抗原之抗體酵素免疫分析試劑 
英文品名
IMx 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、6樓及51號5、6樓 
通關簽審文件編號
DHA00601175501 
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 Each Kit contains:-1 Bottle (5ml) Hepatitis B Surface Antigen (rDNA) (Subtypes ad and ay) Coated Microparticles. Minimum concentration:0.05%-1 Bottle (8ml) Anti-Biotin(Rabbit): Alkaline Phosphatase Conjugate. Minimum concentration:0.05ug/ml-1 Bottle (10ml) 4-Methylumbelliferyl Phosphate. Minimum concentration:1.2mM in Buffer.-1 Bottle (7ml) Hepatitis B Surface Antigen (rDNA) (Subtypes ad and ay): Biotin Conjugate. Minimum concentration: 1ug/ml-1 Bottle (8ml) Mode 1 Calibrator. Recalcified Human Plasma (nonreactive for Anti-HIV-1 and HBsag) containing Anti-HBs at 100 MIU/ml.-Negative Control (8ml) is nonreactive for Anti-HIV-1, HBsAg and Anti-HBs. Positive (8ml) is recalcified human plasma reactive for Anti-HBs, diluted with Negative control.-The six bottles(4ml) of IMx Ausab calibrators prepared with recalcified human plasma. The A calibrator is nonreactive for anti-HIV-1, HBsAg and Anti-HBs. The B through F calibrators are recalcified human plasma positive for Anti-HBs,diluted with the A calibr