邦迪斯人類抗心脂酵素免疫球蛋白G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抗心脂酵素免疫球蛋白G免疫分析套組的英文品名是THE BINDING SITE BINDAZYMETM Human Anticardiolipin IgG Enzyme Immunoassay Kit, 許可證字號是衛署醫器輸字第016134號, 有效日期是2011/03/13, 註銷狀態是已註銷, 註銷日期是2013/01/18, 註銷理由是許可證已逾有效期, 許可證種類是09, 效能是測量人類血清中抗牛心脂蛋白抗體G型免疫球蛋白之濃度,有助於抗磷脂質症候群的診斷。, 主成分略述是Instruction Leaflet: Giving full assay details.\nQC Certificate: Indicating the expected performance of the batch.\nCardiolipin Coated Wells: 12 break..., 醫器規格是MK027, 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016134號 |
註銷狀態 | 已註銷 |
註銷日期 | 2013/01/18 |
註銷理由 | 許可證已逾有效期 |
有效日期 | 2011/03/13 |
發證日期 | 2006/03/13 |
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 | DHA00601613404 |
中文品名 | 邦迪斯人類抗心脂酵素免疫球蛋白G免疫分析套組 |
英文品名 | THE BINDING SITE BINDAZYMETM Human Anticardiolipin IgG Enzyme Immunoassay Kit |
效能 | 測量人類血清中抗牛心脂蛋白抗體G型免疫球蛋白之濃度,有助於抗磷脂質症候群的診斷。 |
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.\nQC Certificate: Indicating the expected performance of the batch.\nCardiolipin Coated Wells: 12 breakapart 8 well strips coated with bovine cardiolipin antigen.\nType II Sample Diluent: 2 bottles containing 50 ml of buffer for sample dilution.\nType II Wash Buffer (20x concentrate): 1 bottle containing 50 ml of a 20-fold concentrated buffer for washing the wells.\nCardiolipin IgG Calibrators: 5 bottles each containing 1.2 ml of diluted human serum, with the following concentrations of anticardiolipin autoantibody: 100, 50, 25, 12.5, 6.25 MPL U/ml.\nCardiolipin IgG Positive Control: 1 bottle containing 1.2 ml of diluted human serum. The expected value is given on the QC certificate.\nCardiolipin Negative Control: 1 bottle containing 1.2 ml of diluted human serum. The expected value is given on the QC certificate.\nCardiolipin IgG Conjugate: 1 bottle containing 12 ml of purified peroxidase labeled antibody.\nTMB Substrate: 1 bottle containing 14 ml TMB substrate. |
醫器規格 | MK027 |
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 | WARSTOCK ROAD, KINGS HEATH, BIRMINGHAM, B14 4RT, UNITED KINGDOM |
製造廠公司地址 | (空) |
製造廠國別 | GB |
製程 | (空) |
異動日期 | 2013/01/18 |
製造許可登錄編號 | (空) |
許可證字號衛署醫器輸字第016134號 |
註銷狀態已註銷 |
註銷日期2013/01/18 |
註銷理由許可證已逾有效期 |
有效日期2011/03/13 |
發證日期2006/03/13 |
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DHA00601613404 |
中文品名邦迪斯人類抗心脂酵素免疫球蛋白G免疫分析套組 |
英文品名THE BINDING SITE BINDAZYMETM Human Anticardiolipin IgG Enzyme Immunoassay Kit |
效能測量人類血清中抗牛心脂蛋白抗體G型免疫球蛋白之濃度,有助於抗磷脂質症候群的診斷。 |
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.\nQC Certificate: Indicating the expected performance of the batch.\nCardiolipin Coated Wells: 12 breakapart 8 well strips coated with bovine cardiolipin antigen.\nType II Sample Diluent: 2 bottles containing 50 ml of buffer for sample dilution.\nType II Wash Buffer (20x concentrate): 1 bottle containing 50 ml of a 20-fold concentrated buffer for washing the wells.\nCardiolipin IgG Calibrators: 5 bottles each containing 1.2 ml of diluted human serum, with the following concentrations of anticardiolipin autoantibody: 100, 50, 25, 12.5, 6.25 MPL U/ml.\nCardiolipin IgG Positive Control: 1 bottle containing 1.2 ml of diluted human serum. The expected value is given on the QC certificate.\nCardiolipin Negative Control: 1 bottle containing 1.2 ml of diluted human serum. The expected value is given on the QC certificate.\nCardiolipin IgG Conjugate: 1 bottle containing 12 ml of purified peroxidase labeled antibody.\nTMB Substrate: 1 bottle containing 14 ml TMB substrate. |
醫器規格MK027 |
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WARSTOCK ROAD, KINGS HEATH, BIRMINGHAM, B14 4RT, UNITED KINGDOM |
製造廠公司地址(空) |
製造廠國別GB |
製程(空) |
異動日期2013/01/18 |
製造許可登錄編號(空) |
邦迪斯人類抗心脂酵素免疫球蛋白G免疫分析套組地圖 [ 導航 ]
邦迪斯人類抗心脂酵素免疫球蛋白G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