適應症
用於體外監測人類血清中專一性抗核抗體(ANAs)的IgG抗體。  
劑型
 
包裝
MK200: 1 KIT 
許可證字號
衛部藥製字第017184號 
註銷狀態
註銷日期
2013-01-18  
註銷理由
838 
有效日期
2011-07-03  
發證日期
2006-07-03  
許可證種類
09 
中文品名
邦迪斯人類抗核抗體篩檢免疫分析套組 
英文品名
THE BINDING SITE BINDAZYME ANA 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
DHA00601718401 
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 ? ANA Coated Well: 12 x 8 well strips coated with a mixture of purified antigens (dsDNA, histone, SSA/Ro (60 and 52Kd), SSB/La, Sm, Sm/RNP, Scl-70, Jo-1, centemeric Antigen).\n? Type III Wash Buffer 20x concentrate: 1 bottle containing 50 mL of a 20x concentrated buffer for washing the wells.\n? Type III Sample Diluent: 2 bottles containing 50 mL of buffer for diluting the samples. Ready to use.\n? ANA Screen Cut-off Control: 1 bottle containing 1.8 mL of duluted stabilized human serum. The expected ANA result is given on the QC certificate. Ready to use.\n? ANA Screen Positive Control: 1 bottle containing 1.8 mL of duluted stabilized human serum. The expected ANA result is given on the QC certificate. Ready to use.\n? ANA Negative Control: 1 bottle containing 1.8 mL of duluted stabilized human serum. The expected ANA result is given on the QC certificate. Ready to use.\n? ANA Screen Conjugate: 1 bottle containing 12 mL of peroxidase labelled antibody to human IgG. Coloured red, ready to use.\n? TMB Substrate