適應症
酵素免疫分析法定性測試人類血清或血漿中之人類免疫缺乏病毒第一型及第二型抗體,篩選用.  
劑型
 
包裝
96 or 480 wells/盒裝 
許可證字號
衛部藥製字第011738號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2027-08-08  
發證日期
2005-08-08  
許可證種類
09 
中文品名
亞培”妙芮絲”人類免疫缺乏病毒抗體檢驗試劑 
英文品名
Murex HIV 1.2.0 
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
DHA00601173801 
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 microwells coated with HIV antigens.2. Sample diluent:One bottle of containing a green buffer solution and detergents. Contains 0.05 ProClin preservative.3. Conjugate: One bottle or two bottles containing HIV antigens conjugated to horseradish peroxidase and freeze dried.4. Conjugate diluent:One bottle or two bottles containing a yellow solution consisting of buffer, bovine protein and detergent. Contains 0.05 ProClin preservative.5. Anti-HIV-1 Positive control serum:One bottle of chemically inactivated human serum containing antibodies to HIV-1 but negative for HBsAg, and antibodies to HCV, in a buffer containing protein. Contains 0.05% bronidox preservative.6. Anti-HIV-2 Positive control serum:One bottle of chemically inactivated human serum containing antibodies to HIV-2 but negative for HBsAg, and antibodies to HCV, in a buffer containing protein. Contains 0.05% bronidox preservative.7. Negative control:One bottle of normal human ser