邦迪斯人類抗心脂酵素免疫球蛋白Ａ免疫分析套組
THE BINDING SITE BINDAZYME Human Anticardiolipin IgA Enzyme Immunoassay kit

適應症
用於體外診斷血清中的抗牛心脂素免疫球蛋白A抗體。  
劑型
 
包裝
MK028: 96 tests/kit 
許可證字號
衛部藥製字第016271號 
註銷狀態
1 
註銷日期
2013-01-18  
註銷理由
838 
有效日期
2011-03-30  
發證日期
2006-03-30  
許可證種類
09 
中文品名
邦迪斯人類抗心脂酵素免疫球蛋白Ａ免疫分析套組 
英文品名
THE BINDING SITE BINDAZYME Human Anticardiolipin IgA Enzyme Immunoassay kit 
藥品類別
C 免疫學及微生物學裝置 
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 
通關簽審文件編號
DHA00601627101 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
THE BINDING SITE LIMITED. WARSTOCK ROAD, KINGS HEATH, BIRMINGHAM, B14 4RT, UNITED KINGDOM GB
THE BINDING SITE LIMITED. P. O. BOX 11712, BIRMINGHAM, B14 4ZB, UNITED KINDOM GB
成份表
處方標示 成分名稱 含量 單位
1 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 IgA 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 IgA Positive Control: 1 bottle containing 1.2 ml of diluted human serum. The expected value is given on the QC certificate.\nCardiolipin IgA Negative Control: 1 bottle containing 1.2 ml of diluted human serum. The expected value is given on the QC certificate.\nCardiolipin IgA Conjugate: 1 bottle containing 12 ml of purified peroxidase labeled antibody.\nTMB Substrate: 1 bottle containing 14 ml TMB subst