適應症
體外診斷人類血清中骨髓過氧化酶(Myeloperoxidase, 簡稱MPO)免疫球蛋白G抗體的存在。  
劑型
 
包裝
MK031 
許可證字號
衛部藥製字第019450號 
註銷狀態
註銷日期
2015-04-24  
註銷理由
838 
有效日期
2013-10-01  
發證日期
2008-10-01  
許可證種類
09 
中文品名
邦迪斯人類MPO酵素免疫分析套組 
英文品名
BINDAZYME TM Human Anti MPO 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
DHA00601945003 
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, U.K. 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?MPO Coated Wells:12 breakapart 8 well strips coated with MPO antigen, colour coded green. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.\n?ANCA Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Coloured yellow.\n?Wash Buffer: 1 bottle containing 50mL of a 20-fold concentrated buffer for washing the wells.\n?MPO Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-MPO antoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL.\n?MPO Positive Control: 1 bottle containing 1.2mL of diluted human serum.\n?MPO Negative Control: 1 bottle containing 1.2mL of diluted human serum.\n?MPO Conjugate: 1 bottle containing 12mL of purified peroxidase labelled antibody to human IgG. Coloured red.\n?TMB Substrate: 1 bottle containing 14mL TMB substrate.\n?Stop Solution: 1 bottle containing 14mL of 3M phosphori