MEDCHECK許可證索引
衛署醫器製字
許可證編號001052
許可證編號001052
國產器材
醫療器材許可證 ／ 國產器材
聯信嗜T型淋巴球病毒I型、II型抗體酵素免疫診斷試劑盒
UBI HTLV-I/II EIA
衛署醫器製字第001052號
本站收錄狀態已註銷
有效日期2007 / 04 / 03
醫療器材級數未載明
這張許可證已註銷（2007/03/08，自請註銷），以下僅供查閱歷史資料。 申請商為 永信藥品工業股份有限公司。 以下整理許可證、規格與製造廠資料，供核對產品身分使用。
許可證資料 依公開資料欄位整理
- 許可證字號
- 衛署醫器製字第001052號
- 申請商
- 永信藥品工業股份有限公司 （查看此申請商全部許可證）
- 統一編號
- 56065601
- 申請商地址
- 台中縣大甲鎮頂店里中山路一段1191號
- 發證日期
- 2003 / 11 / 19
- 有效日期
- 2007 / 04 / 03
- 限制項目
- 國 產
- 資料異動日期
- 2009 / 11 / 13
效能與規格
- 效能
- 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。
- 規格
- 192 TESTS/KIT
- 主成分
- 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.
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.
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.
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.
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.
7.25ML 終止液 (STOP SOLUTION):1瓶 DILUTED SULFURIC ACID SOLUTION (1.0M H2SO4). 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.
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.
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.
製造廠
- 製造商
- 永信藥品工業股份有限公司台中幼獅廠
- 國別
- 台灣
- 廠址
- 台中縣大甲鎮日南里工九路２７號
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