亞培 "妙芮絲" B型肝炎表面抗體檢驗試劑
MUREX ANTI-HBS

適應症
酵素免疫分析法，用於偵測血清或血漿中之B型肝炎表面抗體。  
劑型
 
包裝
96 TESTE OR 480 TESTS。詳如中文仿單核定本。 
許可證字號
衛部藥製字第010730號 
註銷狀態
1 
註銷日期
2018-08-09  
註銷理由
851 
有效日期
2014-06-23  
發證日期
2004-06-23  
許可證種類
09 
中文品名
亞培 "妙芮絲" B型肝炎表面抗體檢驗試劑 
英文品名
MUREX ANTI-HBS 
藥品類別
B 血液學及病理學用裝置 
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
DHA00601073003 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
MUREX BIOTECH LTD. CENTRAL ROAD TEMPLE HILL DARTFORD KENT DAL 5LR U.K. 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 MADE UP OF 96 MICROWELLS COATED WITH HUMAN HBSAG(AD AND BY SUBTYPES).
1 2.ASSAY DILUENT ONE BOTTLE OR FIVE BOTTLES OF BUFFER CONTAINING BOVINE PROTEIN. CONTAINS 0.05% BRONIDOX PRESERVATIVE.
1 3.SAMPLE DILUENT ONE BOTTLE OF BUFFER CONTAINING BOVINE PROTEIN. CONTAINS 0.05%BRONIDOX AND 0.02% SODIUM AZIDE AS PRESERVATIVES.
1 4.NEGATIVE CONTROL ONE BOTTLE OF HUMAN SERUM NON-REACTIVE FOR HBSAG AND ANTIBODIES TO HIV TYPES 1 AND 2 (HIV-1, HIV-2), HCV, AND HBSAG. CONTAINS 0.05%BRONIDOX PRESERVATIVE.
1 5.CUT-OFF CONTROL (10MIU/ML STANDARD)ONE BOTTLE CONTAINING 10MIU/ML ANTI-HBS DILUTED IN A BUFFER CONTAINING BOVINE PROTEIN. CONTAINS 0.05% BRONIDOX AND 0.02% SODIUM AZIDE AS PRESERVATIVES.
1 6.1000MIU/ML STANDARD ONE BOTTLE CONTAINING 1000MIU/ML ANTI-HBS IN A BUFFER CONTAINING BOVINE PROTEIN. CONTAINS 0.05% BRONIDOX AND 0.02% SODIUM AZIDE AS PRESERVATIVES.
1 7.CONJUGATE ONE BOTTLE OR FOUR BOTTLES CONTAINING HEAT INACTIVATED HBSAG (AD AND AY SUBTYPES) CONJUGATED TO HORSERADISH PEROXIDASE DILUTED IN A BUFFER CONTAINING BOVINE PROTEIN AND STABILISERS. CONTAINS 0.025% PROCLIN 300 PRESERVATIVE.
1 8.SUBSTRATE DILUENT ONE BOTTLE CONTAINING A COLOURLESS SOLUTION OF TRI-SODIUM CITRATE AND HYDROGEN PEROXIDE.
1 9.SUBSTRATE CONCENTRATE ONE BOTTLE CONTAINING 3,3'5,5'-TETRAMETHYLBENZIDINE (TMB) AND STABILISERS IN A PINK SOUTION.
1 10.WASH FLUID ONE BOTTLE OR TWO BOTTLES CONTAINING 125ML OF 20 TIMES WORKING STRENGTH GLYCINE/BORATE WASH FLUID. CONTAINS 0.2% BRONIDOX PRESERVATIVE.