適應症
微粒酵素免疫分析法測試人體血清或血漿中之digoxin.  
劑型
 
包裝
100 Tests 
許可證字號
衛部藥製字第012452號 
註銷狀態
註銷日期
2018-08-09  
註銷理由
851 
有效日期
2015-09-20  
發證日期
2005-09-20  
許可證種類
09 
中文品名
亞培愛可信毛地黃第二代檢驗試劑組 
英文品名
ABBOTT AxSYM Digoxin II 
藥品類別
A 臨床化學及臨床毒理學用裝置 
申請商地址
台北市中山區民生東路三段49號5樓、6樓及51號6樓 
通關簽審文件編號
DHA00601245201 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ABBOTT LABORATORIES 100/200 ABBOTT PARK ROAD, ABBOTT PARK, ILLINOIS 60064, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 AxSYM Digoxin II Reagent Pack1. 1 Bottle (15.0mL) Digoxin: Alkaline Phospahtase. Minimum concentration: 0.05μg/mL.2. 1 Bottle (7.6mL) Anti-digoxin coated Microparticels. Minimum concentration: 0.0001%. Preservative: Sodium Azide.3. 1 Bottle (27mL) EMIA buffer containing 0.3M Sodium Chloride in TRIS buffer. 4. 1 Bottle (41.9mL) Digoxin II Probe Wash Solution containing a 2.0 M Sodium Chloride solution.Digoxin Calibrators 6 Bottles (6mL A, 4mL each B-F) of Digoxin Calibrators contain accurately measured amounts of digoxin prepared in recalcified human plasma, nonreactive for HbsAg, HIV-1 Ag, anti-HCV, and anti-HIV-1/HIV-2 yield the following concentrations: 0, 0.5, 1.0, 2.0, 3.0 and 4.0 ng/mL.Digoxin Controls 3 Bottels (8mL each) of Digoxin control cotain accurately measured amounts of digoxin prepared in recalcified human plasma, nonreactive for HbsAg, HIV-1 Ag, anti-HCV, and anti-HIV-1/HIV-2 to yield the following concentration ranges: 0.9, 1.9 and 3.2 ng/mL.