適應症
利用專一性的IgG抗體抗抽取的核內抗原(ENA’S)篩選人類血清,SSA/Ro(60和52 kD),SSB/La,Sm,Sm/RNP, Scl-70,Jo-1可用來測量系統性的風濕疾病。  
劑型
 
包裝
MK201: 96 tests/kit 
許可證字號
衛部藥製字第016270號 
註銷狀態
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
邦迪斯人類抗細胞核萃取物抗體篩檢免疫分析套組 
英文品名
THE BINDING SITE BINDAZYME ENA SCREEN 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
DHA00601627002 
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.\nENA Coated Wells: 12 x 8 well strips coated with a mixture of purified antigens (SSA/Ro (60 and 52 kD), SSB/La, Sm, Sm/RNP, Scl-70 and Jo-1).\nType III Wash Buffer 20x concentrate: 1 bottle containing 50 ml of a 20x concentrated buffer for washing the wells.\nType III Sample Diluent: 2 bottles containing 50 ml of buffer for diluting the samples.\nENA Screen Cut-off Control: 1 bottle containing 1.9 ml of diluted stabilized human serum. The expected ENA result is given on the QC certificate.\nENA Screen Positive Control: 1 bottle containing 1.9 ml of diluted stabilized human serum. The expected ENA result is given on the QC certificate.\nENA Negative Control: 1 bottle containing 1.9 ml of diluted stabilized human serum. The expected ENA result is given on the QC certificate.\nENA Screen Conjugate: 1 bottle containing 12 ml of peroxidase labeled antibody to human IgG.\nTMB Substrate: 1 bottle conta