阿瑪斯蛋白質C試劑組
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名阿瑪斯蛋白質C試劑組的英文品名是AMAX Accuclot Protein C Kit, 許可證字號是衛署醫器輸字第017925號, 有效日期是2012/03/02, 註銷狀態是已註銷, 註銷日期是2014/04/30, 註銷理由是許可證已逾有效期, 許可證種類是09, 效能是利用凝固法來定量測定血漿中蛋白質C的活性。, 主成分略述是PROTEIN C ACTIVATOR, Catalogue No. A 7558 (3 vials)\n Lyophillzed preparation containing highly purified specific Protein C activator from Agkistrodon..., 醫器規格是CRS103-A, 限制項目是輸 入, 申請商名稱是保成儀器有限公司.
| 許可證字號 | 衛署醫器輸字第017925號 |
| 註銷狀態 | 已註銷 |
| 註銷日期 | 2014/04/30 |
| 註銷理由 | 許可證已逾有效期 |
| 有效日期 | 2012/03/02 |
| 發證日期 | 2007/03/02 |
| 許可證種類 | 09 |
| 舊證字號 | (空) |
| 醫療器材級數 | 2 |
| 通關簽審文件編號 | DHA00601792501 |
| 中文品名 | 阿瑪斯蛋白質C試劑組 |
| 英文品名 | AMAX Accuclot Protein C Kit |
| 效能 | 利用凝固法來定量測定血漿中蛋白質C的活性。 |
| 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 | B.7290 因子缺乏試驗 |
| 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 | PROTEIN C ACTIVATOR, Catalogue No. A 7558 (3 vials)\n Lyophillzed preparation containing highly purified specific Protein C activator from Agkistrodon Contortrix (Protac), 1.5 unit, with APTT reagent (rabbit brain cephalin and colloidal sllica activator).\n PROTEIN C DEFICIENT PLASMA, Catalogue No. A 2936 (3 x 1.5 ml) \nLyophillzed human plasma substrate which has been artificaially depleted of Protein C by immunoadsoprption.\n PROTEIN C CONTROL PLASMA, Catalogue No. A 7683 (3 x 0.5 ml)\n Lyophillzed normal human plasma which has been assayed for Protein C antigen and activity against the 1st International Standard for Protein C, 86/622, The assayed value is on the Protein C Control Plasma label.\n PROTEIN C DILUTION BUFFER (10x), Catalogue No. A 7808 (3 x 5 ml) \n Sodium chloride, 1.2 mol/l, imidazole, 0.3 mol/l, with sodium azide, pH 7.35. Solution also contains sufficient protamine suphate to neutralize up to 1 USP unit/ml heparin in the plasma sample. \n \n |
| 醫器規格 | CRS103-A |
| 限制項目 | 輸 入 |
| 申請商名稱 | 保成儀器有限公司 |
| 申請商地址 | 台北市大安區瑞安街１３２號３樓 |
| 申請商統一編號 | 21261769 |
| 製造商名稱 | TRINITY BIOTECH PLC |
| 製造廠廠址 | IDA BUSINESS PARK, BRAY CO., WICKLOW, IRELAND |
| 製造廠公司地址 | (空) |
| 製造廠國別 | IE |
| 製程 | (空) |
| 異動日期 | 2014/05/13 |
| 製造許可登錄編號 | (空) |
許可證字號衛署醫器輸字第017925號 |
註銷狀態已註銷 |
註銷日期2014/04/30 |
註銷理由許可證已逾有效期 |
有效日期2012/03/02 |
發證日期2007/03/02 |
許可證種類09 |
舊證字號(空) |
醫療器材級數2 |
通關簽審文件編號DHA00601792501 |
中文品名阿瑪斯蛋白質C試劑組 |
英文品名AMAX Accuclot Protein C Kit |
效能利用凝固法來定量測定血漿中蛋白質C的活性。 |
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B.7290 因子缺乏試驗 |
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PROTEIN C ACTIVATOR, Catalogue No. A 7558 (3 vials)\n Lyophillzed preparation containing highly purified specific Protein C activator from Agkistrodon Contortrix (Protac), 1.5 unit, with APTT reagent (rabbit brain cephalin and colloidal sllica activator).\n PROTEIN C DEFICIENT PLASMA, Catalogue No. A 2936 (3 x 1.5 ml) \nLyophillzed human plasma substrate which has been artificaially depleted of Protein C by immunoadsoprption.\n PROTEIN C CONTROL PLASMA, Catalogue No. A 7683 (3 x 0.5 ml)\n Lyophillzed normal human plasma which has been assayed for Protein C antigen and activity against the 1st International Standard for Protein C, 86/622, The assayed value is on the Protein C Control Plasma label.\n PROTEIN C DILUTION BUFFER (10x), Catalogue No. A 7808 (3 x 5 ml) \n Sodium chloride, 1.2 mol/l, imidazole, 0.3 mol/l, with sodium azide, pH 7.35. Solution also contains sufficient protamine suphate to neutralize up to 1 USP unit/ml heparin in the plasma sample. \n \n |
醫器規格CRS103-A |
限制項目輸 入 |
申請商名稱保成儀器有限公司 |
申請商地址台北市大安區瑞安街１３２號３樓 |
申請商統一編號21261769 |
製造商名稱TRINITY BIOTECH PLC |
製造廠廠址IDA BUSINESS PARK, BRAY CO., WICKLOW, IRELAND |
製造廠公司地址(空) |
製造廠國別IE |
製程(空) |
異動日期2014/05/13 |
製造許可登錄編號(空) |
阿瑪斯蛋白質C試劑組地圖 [ 導航 ]
阿瑪斯蛋白質C試劑組的地址位於
台北市大安區瑞安街１３２號３樓