邦迪斯人類抗乙型醣蛋白免疫球蛋白Ｍ免疫分析套組
THE BINDING SITE BINDAZYMETM Human Anti-b2GP1 IgM Enzyme Immunoassay Kit

適應症
測量抗β2GP1醣蛋白-1 IgM抗體。  
劑型
 
包裝
MK042 
許可證字號
衛部藥製字第016245號 
註銷狀態
1 
註銷日期
2013-01-18  
註銷理由
838 
有效日期
2011-03-28  
發證日期
2006-03-28  
許可證種類
09 
中文品名
邦迪斯人類抗乙型醣蛋白免疫球蛋白Ｍ免疫分析套組 
英文品名
THE BINDING SITE BINDAZYMETM Human Anti-b2GP1 IgM 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
DHA00601624500 
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 Insstruction Leaflet: giving full assay details.\nQC Certificate: indicating the expected performance of the batch\nβ2GP1 Coated Wells: 12breakpart 8 well strips coated with human β2GP1 antigen.\nType II Sample Diluent: 2 bottles containing 50 ml of buffer for sample dilution.\nWash Buffer (20x Concentrate): 1 bottle containing 50 ml of a 20-fold concentrated buffer for washing the wells.\nβ2GP1 IgM Calibrators: 5 bottles each containing 1.2 ml of diluted human serum, with the following concentrations of anti-β2GP1 autoantibody: 300, 100, 33.3, 11.1, 3.7 U/ml.\nβ2GP1 IgM Positive Control: 1 bottle containing 1.2 ml of diluted human serum. The expected value is given on the QC certificate.\nβ2GP1 Negative Control: 1 bottle containing 1.2 ml of diluted human serum. The expected value is given on the QC certificate.\nβ2GP1 IgM Conjugate: 1 bottle containing 12 ml of purified peroxidase labeled antibody.\nTMB Substrate: 1 bottle containing 14 ml TMB substrate.\nStop Solution: 1 bottle containing 14 ml of 3M phosp