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 EIA

適應症
酵素免疫分析法定性測試人體血清或血漿內之ANTI-HIV1/2 ANTIBODIES,篩檢用。 
劑型
 
包裝
 
許可證字號
衛部成製字第000116號 
註銷狀態
1 
註銷日期
2004-03-12  
註銷理由
823,824 
有效日期
2007-01-11  
發證日期
2002-01-11  
許可證種類
04 
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 EIA 
藥品類別
 
申請商名稱
永信藥品工業股份有限公司  
申請商地址
台中縣大甲鎮中山路一段１１９１號 
通關簽審文件編號
DHA00900011603 
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 台中縣大甲鎮日南里工九路２７號 TW
成份表
處方標示 成分名稱 含量 單位
1 1.1 ML HIV-1 強陽性對照 (HIV-1 EIA STRONGLY REACTIVE CONTROL): 1 瓶 INACTIVATED NORMAL HUMAN SERUM THAT HAS A HIGH TITER OF HIV-1 ANTIBODIES, DILUTED IN NORMAL HUMAN SERUM, CONTAINING 0.1% SODIUM AZIDE AND 0.01% GENTAMICIN AS PRESERVATIVES. STORE AT 2~8°C.
1 2.1 ML HIV-2 弱陽性對照 (HIV-2 EIA WEAKLY REACTIVE CONTROL): 1 瓶 INACTIVATED HUMAN SERUM THAT HAS A LOW TITER OF HIV-2 ANTIBODIES, DILUTED IN NORMAL HUMAN SERUM, CONTAINING 0.1% SODIUM AZIDE AND 0.01% GENTAMICIN. ATORE AT 2~8°C.
1 3.1 ML 陰性對照 (NON-REACTIVE CONTROL):1 瓶 INACTIVATED NORMAL HUMAN SERUM, WHICH IS NON-REACTIVE FOR HEPATITIS B SURFACE ANTIGEN, HIV-1/2 ANTIBODIES, HTLV-I/II ANTIBODIES AND HEPATITIS C ANTIBODIES. CONTAINS PRESERVATIVES: 0.1% SODIUM AZIDE AND 0.01% GENTAMICIN. STORE AT 2~8°C.
1 4.45 ML 樣品稀釋液 (HIV EIA SPECIMEN DILUENT): 1 瓶 PHOSPHATE BUFFERED SALINE SOLUTION CONTAINING SURFACTANT, HEAT-TREATED NORMAL GOAT SERUM, CASEIN, AND BOVINE SERUM ALBUMIN. STORE AT 2~8°C.
1 5.30 ML 酵素結合物稀釋液 (CONIUGATE DILUENT) :1 瓶 PHOSPHATE BUFFERED SALINE SOLUTION CONTAINING SURFACTANT AND HEAT-TREATED NORMAL GOAT SERUM, WITH 0.01% GENTAMICIN AS A PRESERVATIVE. STORE AT 2~8°C.
1 6.25 ML TMB 受質溶液(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 7.25 ML 終止液 (STOP SOLUTION): 1 瓶 DILUTED SULFURIC ACID SOLUTION (1.0M H2SO4). STORE AT 2~30°C.
1 8.150 ML 濃縮洗滌液 (WASH BUFFER CONCENTRATE, 25 X): 1 瓶 A 25 X CONCENTRATE OF PHOSPHATE BUFFERED SALINE WITH SURFACTANT. STORE AT 2~30°C.
1 9. 0.4 ML HIV-1/2 酵素結合物 (HIV-1/2 HRP-CONJUGATE): 1 瓶 HORSERADISH 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, 96 WELLS): 2 盤 EACH PLATE WELL CONTAINS ADSORBED SYNTHETIC HIV-1, HIV-2, AND HIV-1 SUBTYPE O PEPTIDES. STORE AT 2~8°C SEALED WITH SEDICCANT.