適應症
本分析套組用於體外測量人類血清中蛋白水解酵素 (Protease 3, PR3) 自體抗體。  
劑型
 
包裝
MK032 
許可證字號
衛部藥製字第019482號 
註銷狀態
註銷日期
2015-04-24  
註銷理由
838 
有效日期
2013-11-07  
發證日期
2008-11-07  
許可證種類
09 
中文品名
邦迪斯人類 PR3 酵素免疫分析套組 
英文品名
BINDAZYME Human Anti PR3 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
DHA00601948203 
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
成份表
處方標示 成分名稱 含量 單位
1 ● Instruction Leaflet\n● QC Certificate\n● PR3 Coated Wells: 12 breakapart 8 well strips coated with PR3 antigen \n● ANCA Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution.\n● Wash Buffer: 1 bottle containing 50mL of a 20-fold concentrated buffer for washing the wells. \n● PR3 Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-PR3 autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. \n● PR3 Positive Control: 1 bottle containing 1.2mL of diluted human serum. \n● PR3 Negative Control: 1 bottle containing 1.2mL of diluted human serum. \n● PR3 Conjugate: 1 bottle containing 12mL of purified peroxidase labelled antibody to human IgG.\n● TMB Substrate: 1 bottle containing 14mL TMB substrate.\n● Stop Solution: 1 bottle containing 14mL of 3M phosphoric acid.