適應症
檢測人類B淋巴球上之CD19抗原。  
劑型
 
包裝
#340863、#340864、#340865、#340867、#340710、#340711。 
許可證字號
衛部藥製字第016411號 
註銷狀態
註銷日期
2012-10-26  
註銷理由
838 
有效日期
2011-04-19  
發證日期
2006-04-19  
許可證種類
09 
中文品名
"必帝" CD19試劑 
英文品名
"BD" CD19 Reagents 
藥品類別
B 血液學及病理學裝置 
申請商地址
台北市信義區忠孝東路四段560號8樓 
通關簽審文件編號
DHA00601641104 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
BD BIOSCIENCES IMMUNOCYTOMETRY SYSTEMS, A UNIT OF BECTON, DICKINSON AND COMPANY 2350 QUME DRIVE, SAN JOSE, CA95131, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 CD19 (4G7): the CD19 antibody is composed of mouse IgG1 heavy chains and kappa light chains. The monoclonal antibody is supplied as 50 μg purified immunoglobulin in 2.0 ml (25 μg/ml) of phosphate-buffered saline (PBS). The FITC conjugate is supplied as 50 μg in 2.0 ml (25 μg/ml) of PBS. PBS contains gelatin and 0.1% sodium azide. \nAnti-Kappa/Anti-Lambda: anti-Kappa and anti-Lambda are each composed of mouse IgG1 heavy chains and kappa light chains. The Simultest reagent is supplied as a combination of anti-kappa FITC and anti-lambda PE in 1.0 ml of phosphate-buffered saline (PBS). Twenty microliters (20 μl) of the conjugated antibody stain 106 peripheral blood mononuclear cells (PBMCS). PBS contains gelatin and 0.1% sodium azide.\nLambda F(ab’)2/CD19: CD19 is composed of mouse IgG1 heavy chains and kappa light chains. The Simultest reagent is supplied as a combination of Lambda F(ab’)2 FITC and CD19 PE in 1.0 ml of phosphate-buffered saline (PBS). Twenty microliters (20 μl) of the conjugated antibody stain 1