適應症
定性檢驗人體尿液中L.pneumophila serogroup 1 antigen。  
劑型
 
包裝
96 wells 
許可證字號
44000765 
註銷狀態
註銷日期
2012-11-06  
註銷理由
838 
有效日期
2010-10-04  
發證日期
2005-10-04  
許可證種類
09 
中文品名
拜奈克思退伍軍人肺炎尿液抗原酵素免疫分析試劑 
英文品名
Binax Legionella Urinary Antigen EIA 
藥品類別
C 免疫學及微生物學用裝置 
申請商地址
台北市大同區塔城街64號3樓 
通關簽審文件編號
DHA04400076500 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
BINAX, INC 217 READ ST., PORTLAND, MAINE 04103, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Microtiter Wells- Each kit contains 96 Microtiter Wells, coated with purified rabbit anti-Legionella pneumophila serogroup 1 IgG.\nWash Concentrate- One (1) vial with 40mL of 0.1 M Phosphate Buffered Saline, detergent and preservative. Dilute the contents to 400 mL with distilled or deionized water for use.\nPositive Control Urine- One (1) vial with 2 mL of human urine containing Legionella pneumophila serogroup 1 antigen and preservative.\nNegative Control Urine- One (1) vial with 2 mL of normal human urine and preservative. Ready for use.\nHRP Conjugate- One (1) vial with 15 mL of purified rabbit anti-Legionella pneumophila serogroup 1 IgG conjugated to horseradish peroxidase (HRP) in a Tris buffer with a protein stabilizer. Contains less than 0.02% thimerosal as a preservative.\nColor Developer- One (1) vial with 25 mL of chromogenic substrate solution containing tetramethylbenzidine (TMB) and hydrogen peroxide.\nStop Solution- One (1) vial with 10 mL of 1N H2SO4.\n