邦迪斯人類MPO酵素免疫分析套組
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名邦迪斯人類MPO酵素免疫分析套組的英文品名是BINDAZYME TM Human Anti MPO Enzyme Immunoassay Kit, 許可證字號是衛署醫器輸字第019450號, 有效日期是2013/10/01, 註銷狀態是已註銷, 註銷日期是2015/04/24, 註銷理由是許可證已逾有效期, 許可證種類是09, 效能是體外診斷人類血清中骨髓過氧化酶(Myeloperoxidase, 簡稱MPO)免疫球蛋白G抗體的存在。, 主成分略述是?Instruction Leaflet: Giving full assay details.\n?QC Certificate: Indicating the expected performance of the batch.\n?MPO Coated Wells:12 breakapart ..., 醫器規格是MK031, 限制項目是輸 入, 申請商名稱是太暘生物科技股份有限公司.
許可證字號 | 衛署醫器輸字第019450號 |
註銷狀態 | 已註銷 |
註銷日期 | 2015/04/24 |
註銷理由 | 許可證已逾有效期 |
有效日期 | 2013/10/01 |
發證日期 | 2008/10/01 |
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 | DHA00601945003 |
中文品名 | 邦迪斯人類MPO酵素免疫分析套組 |
英文品名 | BINDAZYME TM Human Anti MPO Enzyme Immunoassay Kit |
效能 | 體外診斷人類血清中骨髓過氧化酶(Myeloperoxidase, 簡稱MPO)免疫球蛋白G抗體的存在。 |
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.5660 多發性自體抗體免疫試驗系統 |
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 | ?Instruction Leaflet: Giving full assay details.\n?QC Certificate: Indicating the expected performance of the batch.\n?MPO Coated Wells:12 breakapart 8 well strips coated with MPO antigen, colour coded green. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.\n?ANCA Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Coloured yellow.\n?Wash Buffer: 1 bottle containing 50mL of a 20-fold concentrated buffer for washing the wells.\n?MPO Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-MPO antoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL.\n?MPO Positive Control: 1 bottle containing 1.2mL of diluted human serum.\n?MPO Negative Control: 1 bottle containing 1.2mL of diluted human serum.\n?MPO Conjugate: 1 bottle containing 12mL of purified peroxidase labelled antibody to human IgG. Coloured red.\n?TMB Substrate: 1 bottle containing 14mL TMB substrate.\n?Stop Solution: 1 bottle containing 14mL of 3M phosphori |
醫器規格 | MK031 |
限制項目 | 輸 入 |
申請商名稱 | 太暘生物科技股份有限公司 |
申請商地址 | 新北市汐止區康寧街169巷25號13樓 |
申請商統一編號 | 20921362 |
製造商名稱 | THE BINDING SITE LIMITED. |
製造廠廠址 | P. O. BOX 11712, BIRMINGHAM, B14 4ZB, U.K. |
製造廠公司地址 | (空) |
製造廠國別 | GB |
製程 | (空) |
異動日期 | 2015/04/28 |
製造許可登錄編號 | (空) |
許可證字號衛署醫器輸字第019450號 |
註銷狀態已註銷 |
註銷日期2015/04/24 |
註銷理由許可證已逾有效期 |
有效日期2013/10/01 |
發證日期2008/10/01 |
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DHA00601945003 |
中文品名邦迪斯人類MPO酵素免疫分析套組 |
英文品名BINDAZYME TM Human Anti MPO Enzyme Immunoassay Kit |
效能體外診斷人類血清中骨髓過氧化酶(Myeloperoxidase, 簡稱MPO)免疫球蛋白G抗體的存在。 |
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.5660 多發性自體抗體免疫試驗系統 |
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?Instruction Leaflet: Giving full assay details.\n?QC Certificate: Indicating the expected performance of the batch.\n?MPO Coated Wells:12 breakapart 8 well strips coated with MPO antigen, colour coded green. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.\n?ANCA Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Coloured yellow.\n?Wash Buffer: 1 bottle containing 50mL of a 20-fold concentrated buffer for washing the wells.\n?MPO Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-MPO antoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL.\n?MPO Positive Control: 1 bottle containing 1.2mL of diluted human serum.\n?MPO Negative Control: 1 bottle containing 1.2mL of diluted human serum.\n?MPO Conjugate: 1 bottle containing 12mL of purified peroxidase labelled antibody to human IgG. Coloured red.\n?TMB Substrate: 1 bottle containing 14mL TMB substrate.\n?Stop Solution: 1 bottle containing 14mL of 3M phosphori |
醫器規格MK031 |
限制項目輸 入 |
申請商名稱太暘生物科技股份有限公司 |
申請商地址新北市汐止區康寧街169巷25號13樓 |
申請商統一編號20921362 |
製造商名稱THE BINDING SITE LIMITED. |
製造廠廠址P. O. BOX 11712, BIRMINGHAM, B14 4ZB, U.K. |
製造廠公司地址(空) |
製造廠國別GB |
製程(空) |
異動日期2015/04/28 |
製造許可登錄編號(空) |
邦迪斯人類MPO酵素免疫分析套組地圖 [ 導航 ]
邦迪斯人類MPO酵素免疫分析套組的地址位於
新北市汐止區康寧街169巷25號13樓