亞培 "妙芮絲" 人類嗜T淋巴球病毒第一型及第二型抗體檢驗試劑
MUREX HTLV I+II

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嗜T淋巴球病毒第一型及第二型抗體，篩選用。 
劑型
 
包裝
 
許可證字號
衛部醫器陸輸字第000720號 
註銷狀態
1 
註銷日期
2005-10-31  
註銷理由
824,823 
有效日期
2002-08-12  
發證日期
2007-08-12  
許可證種類
04 
中文品名
亞培 "妙芮絲" 人類嗜T淋巴球病毒第一型及第二型抗體檢驗試劑 
英文品名
MUREX HTLV I+II 
藥品類別
 
申請商名稱
美商亞培股份有限公司台灣分公司  
申請商地址
台北巿民生東路三段４９號６樓 
通關簽審文件編號
DHA01000072007 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
MUREX BIOTECH LIMITED CENTRAL ROAD. TEMPLE HILL. DARTFORD, KENT DA1 5LR, ENGLAND GB
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 OF 96 WELLS COATED WITH HTLV-I AND II ANTIGENS.
1 2.SAMPLE DILUENT: ONE BOTTLE CONTAINING BUFFER AND DETERGENTS. CONTAINS 0.05% BRONIDOX PRESERVATIVE.
1 3.NEGATIVE CONTROL: ONE BOTTLE CONTAINING NORMAL HUMAN SERUM NON-REACTIVE FOR HBSAG AND ANTIBODY TO HIV-1 AND HIV-2, HCV AND HTLV-I AND HTLV-II, DILUTED IN A BOVINE PROTEIN BUFFER. CONTAINS 0.05% BRONIDOX PRESERVATIVE.
1 4.ANTI-HTLV PSOTIVIE CONTROL: ONE BOTTLE CONTAINING INACTIVATED HUMAN SSERUM CONTAINING ANTIBODIES TO HTLV BUT NEGATIVE FOR HEPATITIS B SURFACE ANTIGEN (HBSAG) AND NEGATIVE FOR ANTIBODIES TO HIV-1 AND HIV-2, DILUTED IN A BUFFER CONTAINING BOVINE PROTEIN. CONTAINS 0.05% BRONIDOX PRESERVATIVE.
1 5.CONJUGATE: ONE BOTTLE CONTAINING HTLV ANTIGENS CONJUGATED TO HORSERADISH PEROXIDASE AND FREEZE DRIED.
1 6.CONJUGATE DILUENT: ONE BOTTLE CONTAINING A RED SOLUTIN CONSISTING OF BUFFER, BOVINE PROTEIN AND DETERGENT. CONTAINS 0.05 BRONIDOX PRESERVATIVE.
1 7.SUBSTRATEDILUENT: ONE BOTTLE CONTAINING A COLOURLESS SOLUTION OF TRI-SODIUM, CITRATE AND HUDROGEN.
1 8.SUBSTRATE CONCENTRATE: ONE BOTTLE CONTAINING 3,3',5,5',-TERAMETHYLBENZIDINE (TMB) AND STABILIZERS IN A PINK SOLUITON.
1 9.WASH FLUID: ONE BOTTLE CONTAINING 125 ML OF 20 TIMES WORKING STRENGTH GLYCINE/BORATE WASH FLUID. CONTAINS 0.2% BRONIDOX PRESERVATIVE.