適應症
採用單步驟酵素免疫分析技術之「三明治法」,偵測人體血清或血漿中B型肝炎病毒表面抗原。  
劑型
 
包裝
72346: 96 tests72348: 480 tests 
許可證字號
衛部藥製字第021665號 
註銷狀態
註銷日期
2018-06-28  
註銷理由
888 
有效日期
2015-10-25  
發證日期
2010-10-25  
許可證種類
09 
中文品名
莫芮莎B型肝炎表面抗原篩檢試劑 
英文品名
MONOLISA HBs Ag ULTRA 
藥品類別
B 血液學及病理學裝置 
申請商地址
台北市松山區南京東路4段126號14樓 
通關簽審文件編號
DHA00602166503 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
BIO-RAD 3BD RAYMOND POINCARE 92430 MARNES-LA-COQUETTE FRANCE FR
成份表
處方標示 成分名稱 含量 單位
1 R1: MICROPLATE \n12 strips of 8 wells each, coated with monoclonal anti-HBs antibodies (mouse)\nR2: CONCENTRATED WASHING SOLUTION (20×) \nTris NaCl buffer pH 7.4, ProClin 300 (0.04%)\nR3: NEGATIVE CONTROL \nTris HCl buffer containing BSA, ProClin 300 (0.1%)\nR4: POSITIVE CONTROL (HUMAN)\nTris HCl buffer containing BSA with addition of mixture of purified HBs Ag from ad and ay subtypes, ProClin 300 (0.1%)\nR6: CONJUGATE DILUENT \nTris HCl buffer pH 7.4 containing BSA, Tween® 20, bovine immunoglobulins and mouse immunoglobulins with sample addition control reagent, ProClin 300 (0.1%), Ciprofloxacine (10 μg/ml)\nR7: CONJUGATE \nMouse Monoclonal anti-HBs antibodies and Goat polyclonal anti-HBs antibodies bound to the peroxidase. Lyophilized.\nR8: SUBSTRATED BUFFER \nCitric acid and Sodium acetate solution pH 4.0 containing H2O2 (0.015%) and DMSO (4%)\nR9: CHROMOGEN PINK COLOURED \nSolution containing tetramethyl benzidine (TMB)\nR10: STOPPING SOLUTION \n1N sulphuric acid solution