適應症
酵素免疫分析法定性測試人體血清或血漿中之C型肝炎病毒抗體。  
劑型
 
包裝
盒裝 
許可證字號
衛部藥製字第011741號 
註銷狀態
註銷日期
2022-04-18  
註銷理由
841 
有效日期
2022-08-12  
發證日期
2005-08-08  
許可證種類
09 
中文品名
亞培”妙芮絲”C型肝炎病毒抗體檢驗試劑(第四代) 
英文品名
Murex Anti-HCV Version 4.0 
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
DHA00601174100 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DiaSorin South Africa (Pty) Ltd. 22 Kyalami Boulevard, Kyalami Business Park, Kyalami 1684, South Africa ZA
成份表
處方標示 成分名稱 含量 單位
1 1. Antigen coated wells:One plate or five plates each made up of 96 microwells coated with purified HCV antigens.2. Sample diluent:One bottle of 20ml, or one bottle of 100ml of Buffer containing proteins of bovine and porcine origin. Contains 0.05% bronidox and 0.1% sodium azide as preservative.3. Negative control:One bottle containing normal human serum Diluted in a buffer containing protein of bovine origin. The Human serum has been tested and found to be non-reactive for Antibodies to HCV and to human immunodeficiency virus types 1 and 2 (HIV-1 and HIV-2) and also non-reactive for hepatitis B surface antigen (HBsAg). Contains 0.05% Bronidox preservative.4. Anti-HTLV positive control:One bottle of human serum containing Antibodies to HCV diluted in a buffer containing protein of bovine origin. The human serum was found to be non-reactive for HBsAg and antibodies to HIV-1 and HIV-2 and has been inactivated according to published procedures. Contains 0.05% Bronidox preservat