聯信人類免疫缺乏病毒1型和2型抗體酵素免疫診斷試劑盒
UBI HIV-1/2 ETA

適應症
酵素免疫分析法定性測試人體血清或血漿內之嗜T型淋巴球病毒I 型、II型抗體。  
劑型
 
包裝
192 TEST/KIT 
許可證字號
衛署醫器製字第001053號 
註銷狀態
1 
註銷日期
2011-08-24  
註銷理由
841 
有效日期
2012-01-11  
發證日期
2003-11-19  
許可證種類
09 
中文品名
聯信人類免疫缺乏病毒1型和2型抗體酵素免疫診斷試劑盒 
英文品名
UBI HIV-1/2 ETA 
藥品類別
B 血液學及病理學用裝置 
申請商名稱
永信藥品工業股份有限公司  
申請商地址
台中市大甲區頂店里中山路一段1191號 
通關簽審文件編號
DHY00500105308 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
永信藥品工業股份有限公司台中幼獅廠 台中市大甲區日南里工九路２７號 TW
成份表
處方標示 成分名稱 含量 單位
1 1.1ML HTLV-I 強陽性對照 (HTLV-I STRONGLY REACTIVE CONTROL):1瓶INACTIVATED NORMAL HUMAN SERUM CONTAINING HTLV-I ANTIBODIES, NON-REACTIVE FOR HEPATITIS B SURFACE ANTIGEN AND HIV-1/2 ANTIBODIES. CONTAINS PRESERVATIVES:0.1% SODIUM AZIDE AND 0.01% GENTAMICIN. STORE AT 2-8°C.
1 2.1ML HTLV-II 弱陽性對照 (HTLV-II WEAKLY REACTIVE CONTROL):1瓶INACTIVATED HUMAN SERUM CONTAINING HTLV-II ANTIBODIES, SPECIFIC FOR PEPTIDE ANTIGENS. NON-REACTIVE FOR HEPATITIS B SURFACE ANTIGEN AND HIV-1/2 ANTIBODIES. CONTAINS PRESERVATIVES:0.1% SODIUM AZIDE AND 0.01% GENTAMICIN. STORE AT 2-8°C.
1 3.1ML 陰性對照 (NON-REACTIVE CONTROL):1瓶 INACTIVTED NORMAL HUMAN SREUM, WHICH IS NON-REACTIVE FOR HEPATITIS B SURFACE ANTIGEN, HIV-1/2 ANTIBODIES, HTLV-I/II ANTIBODIES AND HEPATITIS C ANTBODIES. CONTAINS PRESERVATIVES:0.1% SODIUM AZIDE AND 0.01% GENTAMICIN. STORE AT 2-8°C.
1 4.45ML 樣品稀釋液 (HIV EIA SPECIMEN SILUENT):1瓶 PHOSPHATE BUFFERED SLINE SOLUTION CONTAINING SURFACTANT, HEAT-TREATED NORMAL GOAT SERUM CASEIN,AND BOVINE SERUM ALBUMIN. STORE AT 2-8°C.
1 5.30ML 酵素結合物稀釋液(CONJIUGATE DILUENT):1 PHOSPHATE BUFFERED SALINE SOLUTION CONTAINING SURFACTANT AND HEAT-TREATED NORMAL SERUM, WITH 0.01% GENTAMICIN AS A PRESERVATIVE. STORE AT 2-8°C.
1 6.25ML TMB 受質 (TMB SUBSTRATE SOLUTION):1瓶3,3',5,5'-TETRAMETHYLBENZIDINE (TMB) DISSOLVED IN CITRATE-PHOSPHATE BUFFER AND H2O2 SOLUTION. STORE AT 2-8°C.
1 7.25ML 終止液 (STOP SOLUTION):1瓶 DILUTED SULFURIC ACID SOLUTION (1.0M H2SO4). STORE AT 2-30°C.
1 8.150ML 濃縮洗滌液 (WASH BUFFER CONCENTRATE, 25X):1瓶 A 25 X CONCENTRATE OF PHOSPHATE BUFFERED SALINE WITH SURFACTANT.STORE AT 2-30°C.
1 9.0.4ML HIV-1/2 酵素結合物 (HIV-1/2 HRP-CONJUGATE):1瓶 HORSEADISH PEROXIDASE-CONJUGATED GOAT ANTI-HUMAN IGG ANTIBODIES, WITH 0.01% GENTAMICIN AND 0.05% 4-DIMETHYLAMINOANTIPYRINE. STORE AT 2-8°C.
1 10.96 孔 HIV-1/2 反應盤 (HIV-1/2 PLATE, 96WELLS):2盤 EACH PLATE WELL CONTAINS ADSORBED SYNTHETIC HIV-1, HIV-2, AND HIV-1SUBTYPE O PEPTIDES. STORE AT 2-8°C SEALED WITH DESICCANT.