適應症
酵素免疫分析法定性測試人類血清或血漿中之B型肝炎病毒表面抗原.  
劑型
 
包裝
96 or 480 wells/盒裝 
許可證字號
衛部藥製字第011740號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2027-08-06  
發證日期
2005-08-08  
許可證種類
09 
中文品名
亞培”妙芮絲”B型肝炎表面抗原第三代檢驗試劑 
英文品名
Murex HBsAg Version 3 
藥品類別
B 血液學及病理學用裝置 
申請商地址
臺北市中山區民生東路3段49號5樓、6樓及51號6樓 
通關簽審文件編號
DHA00601174001 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIASORIN S.P.A. UK BRANCH Central Road, Dartford, DA1 5LR, United Kingdom GB
成份表
處方標示 成分名稱 含量 單位
1 1.Antibody coated well:One plate or five plates of 96 wells coated With mouse monoclonal antibody to HBsAg.2.Sample diluent:One bottle of green/brown buffer containing detergents and proteins of goat and bovine origin. Contains 0.05% ProClin 300 preservative.3.Negative control:One bottle containing normal human serum non- reactive for HBsAg and antibodies to HIV types 1 and 2, HCV and HTLV-I/II. The serum is diluted in a buffer containing protein of bovine origin. Contains 0.05% Bronidox preservative.4.Positive control:One bottle containing inactivated human serumpositive for HBsAg but negative for antibodies HIV/1 and HIV/2and HCV. The serum is diluted in a buffer containing protein ofbovine origin. Contains 0.05% bronidox preservative.5.Conjugate:One bottle or two bottles containing horseradish-peroxidase labeled goat antibody to HBsAg in a red buffer containingproteins of bovine and goat origin. Contains 0.05% ProClin 300preservative.6.Substrate diluent:One bottle co