適應症
微粒酵素免疫分析法定性測試人體血清或血漿中B型肝炎e抗原  
劑型
 
包裝
100 次測試/盒 
許可證字號
衛部藥製字第011754號 
註銷狀態
註銷日期
2018-08-09  
註銷理由
851 
有效日期
2016-04-24  
發證日期
2005-08-08  
許可證種類
09 
中文品名
亞培愛可信B型肝炎e抗原第二代檢驗試劑 
英文品名
Abbott AxSYM HBe 2.0 
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
DHA00601175409 
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 HBe 2.0 Reagent Pack1. 1 Bottle(6.9ml) Antibody to Hepatitis B e Antigen (Mouse, Monoclonal) Coated microparticles in TRIS buffer with protein stabilizers. Minimum concentration: 0.005% solids. Preservative: Sodium azide.2. 1 Bottle(10.3ml) Antibody to Hepatitis B e Antigen (Mouse, Monoclonal):Alkaline Phosphate Conjugate in HRIS buffer with protein stabilizers. Minimum concentration: 0.1ug/ml. Preservatives: Sodium azide and antimicobial agents.3. 1 Bottle(19.2ml) Wetting solution prepared TRIS buffer with protein stabilizers. Preservative: Antimicrobial agents.4. 1 Bottle(50.2ml) Specimen diluent containing sodium chloride in TRIS buffer. Preservatives: Sodium azide and antimicrobial agents.1 Bottle(4ml) AxSYM HBe 2.0 Index Calibrator (concentration:0.280PEI U/ml) containing recombinant DNA derived HbeAg in TRIS buffer with protein stabilizers. Preservative: Sodium azide.AxSYM HBe 2.0 Controls1 Bottle (9.0ml) of AsSYM HBe 2.0 Negative control is prepared in TRIS buffer with protein staAxSYM HBe 2.0 Re