速樂定TP檢驗試劑
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名速樂定TP檢驗試劑的英文品名是SERODIA-TP, 許可證字號是衛署醫器輸字第015462號, 有效日期是2015/12/12, 註銷狀態是已註銷, 註銷日期是2016/03/22, 註銷理由是自請註銷, 許可證種類是09, 效能是血球凝集法檢測人血清及血漿中之梅毒Treponema Pallidum抗體。, 主成分略述是(A.) RECONSTITUTING SOLUTION (Liquid) : \nThis reagent is used for reconstitution of lyophilized Sensitized Cells and Un sensitized Cells,and consists..., 醫器規格是100T/Kit (25×4)、500T/KIT( 100×5), 限制項目是輸 入, 申請商名稱是台富製藥股份有限公司.
| 許可證字號 | 衛署醫器輸字第015462號 |
| 註銷狀態 | 已註銷 |
| 註銷日期 | 2016/03/22 |
| 註銷理由 | 自請註銷 |
| 有效日期 | 2015/12/12 |
| 發證日期 | 2005/12/12 |
| 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 | DHA00601546203 |
| 中文品名 | 速樂定TP檢驗試劑 |
| 英文品名 | SERODIA-TP |
| 效能 | 血球凝集法檢測人血清及血漿中之梅毒Treponema Pallidum抗體。 |
| 劑型 | (空) |
| 包裝 | (空) |
| 醫器主類別一 | C 免疫學及微生物學 |
| 醫器次類別一 | C.3830 梅毒螺旋體螺旋體試劑 |
| 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 | (A.) RECONSTITUTING SOLUTION (Liquid) : \nThis reagent is used for reconstitution of lyophilized Sensitized Cells and Un sensitized Cells,and consists of a phosphate buffered saline solution containing Normal rabbit serum and Sodium Azide (0.1﹪).\n(B.) SERUM DILUENT (Liquid): \nThis reagent is used for dilution of test serum and reconstitution of Serodia-HAAbsorbent and consists of a phosphate buffered saline solution containing Normal rabbit testicular extract,cell components of sonicated Reiter T. Phagedenis, normal rabbit serum and Sodium Azide (0.1﹪).\n(C.) SENSITIZED CELLS (Lyophilized)\nFixed chicken erythrocytes sensitized with components of pathogenic\nTreponema Pallidum(Nichols Strain). Each vial must be rehydrated withthe prescribed quantity of Reconstituting Solution( to obtain 0.375% suspension) before utilization.\n(D.) UNSENSITIZED CELLS (Lyophilized)\nFixed chicken erythrocytes. The reagent of each vial must be rehydrated with the prescribed quantity of Reconstituting Solution ( to obtain 0.37 (E.) POSITIVE CONTROL (Liquid) : \nThis control is prepared from rabbit serum containing T. Pallidum and Sodium Azide (0.1﹪). The control should show a titer of 1:320 (Final Dilution).\n(F.) SERODIA-HA ABSOBENT (Lyophilized)\nUse for absorption of test sera which showed agglutination with unsensitized Cells The reagent must be rehydrated with the prescribed quantity of SERUM DILUENT. |
| 醫器規格 | 100T/Kit (25×4)、500T/KIT( 100×5) |
| 限制項目 | 輸 入 |
| 申請商名稱 | 台富製藥股份有限公司 |
| 申請商地址 | 桃園市大園區和平西路一段391號 |
| 申請商統一編號 | 05084773 |
| 製造商名稱 | FUJIREBIO INC., HACHIOJI FACILITY |
| 製造廠廠址 | 51, KOMIYA-CHO, HACHIOJI-SHI TOKYO, 192-0031 JAPAN |
| 製造廠公司地址 | (空) |
| 製造廠國別 | JP |
| 製程 | (空) |
| 異動日期 | 2016/03/23 |
| 製造許可登錄編號 | (空) |
許可證字號衛署醫器輸字第015462號 |
註銷狀態已註銷 |
註銷日期2016/03/22 |
註銷理由自請註銷 |
有效日期2015/12/12 |
發證日期2005/12/12 |
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DHA00601546203 |
中文品名速樂定TP檢驗試劑 |
英文品名SERODIA-TP |
效能血球凝集法檢測人血清及血漿中之梅毒Treponema Pallidum抗體。 |
劑型(空) |
包裝(空) |
醫器主類別一C 免疫學及微生物學 |
醫器次類別一C.3830 梅毒螺旋體螺旋體試劑 |
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(A.) RECONSTITUTING SOLUTION (Liquid) : \nThis reagent is used for reconstitution of lyophilized Sensitized Cells and Un sensitized Cells,and consists of a phosphate buffered saline solution containing Normal rabbit serum and Sodium Azide (0.1﹪).\n(B.) SERUM DILUENT (Liquid): \nThis reagent is used for dilution of test serum and reconstitution of Serodia-HAAbsorbent and consists of a phosphate buffered saline solution containing Normal rabbit testicular extract,cell components of sonicated Reiter T. Phagedenis, normal rabbit serum and Sodium Azide (0.1﹪).\n(C.) SENSITIZED CELLS (Lyophilized)\nFixed chicken erythrocytes sensitized with components of pathogenic\nTreponema Pallidum(Nichols Strain). Each vial must be rehydrated withthe prescribed quantity of Reconstituting Solution( to obtain 0.375% suspension) before utilization.\n(D.) UNSENSITIZED CELLS (Lyophilized)\nFixed chicken erythrocytes. The reagent of each vial must be rehydrated with the prescribed quantity of Reconstituting Solution ( to obtain 0.37 (E.) POSITIVE CONTROL (Liquid) : \nThis control is prepared from rabbit serum containing T. Pallidum and Sodium Azide (0.1﹪). The control should show a titer of 1:320 (Final Dilution).\n(F.) SERODIA-HA ABSOBENT (Lyophilized)\nUse for absorption of test sera which showed agglutination with unsensitized Cells The reagent must be rehydrated with the prescribed quantity of SERUM DILUENT. |
醫器規格100T/Kit (25×4)、500T/KIT( 100×5) |
限制項目輸 入 |
申請商名稱台富製藥股份有限公司 |
申請商地址桃園市大園區和平西路一段391號 |
申請商統一編號05084773 |
製造商名稱FUJIREBIO INC., HACHIOJI FACILITY |
製造廠廠址51, KOMIYA-CHO, HACHIOJI-SHI TOKYO, 192-0031 JAPAN |
製造廠公司地址(空) |
製造廠國別JP |
製程(空) |
異動日期2016/03/23 |
製造許可登錄編號(空) |
速樂定TP檢驗試劑地圖 [ 導航 ]
速樂定TP檢驗試劑的地址位於
桃園市大園區和平西路一段391號