聯信C型肝炎病毒抗體酵素免疫診斷試劑盒
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名聯信C型肝炎病毒抗體酵素免疫診斷試劑盒的英文品名是UBI HCV EIA, 許可證字號是衛署醫器製字第001054號, 有效日期是2012/01/11, 註銷狀態是已註銷, 註銷日期是2011/08/24, 註銷理由是自請註銷, 許可證種類是09, 效能是酵素免疫分析法定性測試人體血清或血漿內之C型肝炎病毒抗體, 主成分略述是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/..., 醫器規格是192 TESTS/KIT, 限制項目是國 產, 申請商名稱是永信藥品工業股份有限公司.
| 許可證字號 | 衛署醫器製字第001054號 |
| 註銷狀態 | 已註銷 |
| 註銷日期 | 2011/08/24 |
| 註銷理由 | 自請註銷 |
| 有效日期 | 2012/01/11 |
| 發證日期 | 2003/11/19 |
| 許可證種類 | 09 |
| 舊證字號 | (空) |
| 醫療器材級數 | (空) |
| 通關簽審文件編號 | DHY00500105400 |
| 中文品名 | 聯信C型肝炎病毒抗體酵素免疫診斷試劑盒 |
| 英文品名 | UBI HCV EIA |
| 效能 | 酵素免疫分析法定性測試人體血清或血漿內之C型肝炎病毒抗體 |
| 劑型 | (空) |
| 包裝 | (空) |
| 醫器主類別一 | B 血液學、病理學及基因學 |
| 醫器次類別一 | (空) |
| 醫器主類別二 | (空) |
| 醫器次類別二 | (空) |
| 醫器主類別三 | (空) |
| 醫器次類別三 | (空) |
| 主成分略述 | 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. 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. 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. 1.1ML 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. 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. 7.25ML 終止液 (STOP SOLUTION):1瓶 DILUTED SULFURIC ACID SOLUTION (1.0M H2SO4). STORE AT 2-30°C. 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. 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. 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. 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. |
| 醫器規格 | 192 TESTS/KIT |
| 限制項目 | 國 產 |
| 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 |
| 申請商統一編號 | 56065601 |
| 製造商名稱 | 永信藥品工業股份有限公司台中幼獅廠 |
| 製造廠廠址 | 台中市大甲區日南里工九路２７號 |
| 製造廠公司地址 | (空) |
| 製造廠國別 | TW |
| 製程 | (空) |
| 異動日期 | 2011/09/06 |
| 製造許可登錄編號 | (空) |
許可證字號衛署醫器製字第001054號 |
註銷狀態已註銷 |
註銷日期2011/08/24 |
註銷理由自請註銷 |
有效日期2012/01/11 |
發證日期2003/11/19 |
許可證種類09 |
舊證字號(空) |
醫療器材級數(空) |
通關簽審文件編號DHY00500105400 |
中文品名聯信C型肝炎病毒抗體酵素免疫診斷試劑盒 |
英文品名UBI HCV EIA |
效能酵素免疫分析法定性測試人體血清或血漿內之C型肝炎病毒抗體 |
劑型(空) |
包裝(空) |
醫器主類別一B 血液學、病理學及基因學 |
醫器次類別一(空) |
醫器主類別二(空) |
醫器次類別二(空) |
醫器主類別三(空) |
醫器次類別三(空) |
主成分略述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. 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. 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. 1.1ML 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. 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. 7.25ML 終止液 (STOP SOLUTION):1瓶 DILUTED SULFURIC ACID SOLUTION (1.0M H2SO4). STORE AT 2-30°C. 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. 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. 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. 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. |
醫器規格192 TESTS/KIT |
限制項目國 產 |
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 |
申請商統一編號56065601 |
製造商名稱永信藥品工業股份有限公司台中幼獅廠 |
製造廠廠址台中市大甲區日南里工九路２７號 |
製造廠公司地址(空) |
製造廠國別TW |
製程(空) |
異動日期2011/09/06 |
製造許可登錄編號(空) |
聯信C型肝炎病毒抗體酵素免疫診斷試劑盒地圖 [ 導航 ]
聯信C型肝炎病毒抗體酵素免疫診斷試劑盒的地址位於
台中市大甲區頂店里中山路一段1191號