亞培 "妙芮絲" C型肝炎病毒抗體檢驗試劑 (第四代)
Murex Anti-HCV Version 4.0

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
 
許可證字號
衛部醫器陸輸字第000721號 
註銷狀態
1 
註銷日期
2005-10-31  
註銷理由
824,823 
有效日期
2007-08-12  
發證日期
2002-08-12  
許可證種類
04 
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
 
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
DHA01000072109 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
MUREX BIOTECH S.A. (PTY) LTD. 186 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 AN TIGENS.
1 2.SAMPLE SILUENT: ONE BOTTLE OF 20 ML, OR ONE BOTTLE OF 100 ML OF BUFFER CONTAINING PROTEINS OF BOVINE AND PORCINE ORIGIN. CONTAINS 0.05% BRONIDOX AND 0.1% SODIUM AZIDE AS PRESERVATIVE.
1 3.NEGATIVE CONTROL: ONE BOTTLE CONTAINING NORMAL HUMAN SERUM DILUTED IN 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 2) AND ALSO NON-REACTIVE FOR HEPATITIS BSURFACE ANTIGEN (HBSAG). CONTAINS 0.05% BRONIDOX AS PRESERVATIVE.
1 4.ANTI-HTLV POSITIVE CONTROL: ONE BOTTLE OF HUMAN SERUM CONTAINING ANTIBODIES TO HCV DILUTED IN A BUFFER CONTAIN-PROTEIN OF BOVINE ORIGIN. THE HUMN SERUM WASFOUND 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 PRESERVATIVE.
1 5.CONJUGATE DILUENT: ONE BOTTLE OR THREE BOTTLES OF BUFFER CONTAINING INORGANIC SALTS AND BOVINE PROTEIN WITH 0.05% BRONIDOX PRESERVATIVE.
1 6.CONJUGATE: ONE BOTTLE OR THREE BOTTLES CONTAINING FREEZE DRIED HORSERADISH PEROXIDASE-LABELLED MOUSE MONOCLONAL ANTIBODY TO HUMAN IGG IN A BOVINEPROTEIN BASE.
1 7.SUBSTRATE DILUENT: ONE BOTTLE CONTAINING A COLORULESS SOLUTION OF TRI-SODIUM, CITRATE AND HYDROGEN PEROXIDE.
1 8.SUBSTRATE CONCENTRATE: ONE BOTTLE CONTAINING 3,3',5,5'-TETRAMETHYLBENZIDINE (TMB) AND STABILIZERS IN A PINK SOLUTION
1 9.WASH FLUID: ONE BOTTLE OR TWO BOTTLES CONTAINING 125ML OF 20 TIMES WORKING STRENGTH GLYCINE/BORATE WASH FLUID. CONTAINS 0.2 % BRONIDOX PRESERVATIVE.