邦迪斯人類抗乙型醣蛋白免疫球蛋白G免疫分析套組
THE BINDING SITE BINDAZYME Human Anti B2GP1 IgG Enzyme Immunoassay Kit

適應症
用於測量人體血清中抗B2GP1的IgG抗體。  
劑型
 
包裝
MK040: 96 wells/kit 
許可證字號
44002620 
註銷狀態
1 
註銷日期
2013-01-18  
註銷理由
838 
有效日期
2011-02-10  
發證日期
2006-02-10  
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G免疫分析套組 
英文品名
THE BINDING SITE BINDAZYME Human Anti B2GP1 IgG 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
DHA04400262007 
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.\n• QC Certificate: Indicating the expected performance of the batch\n• β2GP1 Coated Wells: 12 breakapart 8 well strips coated with human β2GP1 antigen. The plate is packaged in a re-sealable foil bag containing two desiccant pouches.\n• Type II Sample Diluent: 2 bottles containing 50 mL of buffer for sample dilution. Coloured yellow, ready to use.\n• Wash Buffer (20x Concentrate): 1 bottle containing 50 mL of a 20-fold concentrated buffer for washing the wells.\n• β2GP1 IgG 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. Ready to use.\n• β2GP1 IgG Positive Control: 1 bottle containing 1.2 mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.\n• β2GP1 Negative Control: 1 bottle containing 1.2 mL of diluted human serum. The expected value is given on the QC certificate.