適應症
測量人類血清中特異性G型免疫球蛋白自體抗體對抗雙股去氧核醣核酸,有助於系統性紅斑性狼瘡(SLE)的診斷。  
劑型
 
包裝
MK017 
許可證字號
衛部藥製字第016133號 
註銷狀態
註銷日期
2013-01-18  
註銷理由
838 
有效日期
2011-03-13  
發證日期
2006-03-13  
許可證種類
09 
中文品名
邦迪斯人類抗雙股螺旋去氧核醣核酸免疫分析套組 
英文品名
THE BINDING SITE BINDAZYMETM Human Anti dsDNA Enzyme Immunoassay kit 
藥品類別
C 免疫學及微生物學裝置 
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
DHA00601613302 
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. 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.\ndsDNA Coated Wells: 12 breakapart 8 well strips coated with calf thymus dsDNA antigen. Each plate is packaged in a resealable foil bag containing two desiccant pouches.\nType III Sample Diluent: 2 bottles containing 50 ml of buffer for sample diluent.\nType III Wash Buffer (20x Concentrate): 1 bottle containing 50 ml of a 20-fold concentrated buffer for washing the wells.\ndsDNA Calibrators: 5 bottles each containing 1.2 ml of diluted human serum, with the following concentrations of anti-dsDNA autoantibody: 1000, 333, 111, 37, 12.3 IU/ml.\ndsDNA Positive Control: 1 bottle containing 1.2 ml of diluted human serum. The expected value is given on the QC certificate.\ndsDNA Negative Control: 1 bottle containing 1.2 ml of diluted human serum. The expected value is given on the QC certificate.\ndsDNA Single Strandard Control: 1 bottle containing 1.2 ml of diluted human serum. The expected value is gi