適應症
利用微粒酵素免疫分析法(MELA),定量測試人類血清或血漿中之心血管藥物 digoxin。  
劑型
 
包裝
# 6L07-01# 6L07-10# 6L07-20 
許可證字號
衛部藥製字第018261號 
註銷狀態
註銷日期
2019-11-18  
註銷理由
851 
有效日期
2017-05-01  
發證日期
2007-05-01  
許可證種類
09 
中文品名
亞培愛可信毛地黃第三代檢驗試劑組 
英文品名
ABBOTT AxSYM Digoxin III 
藥品類別
A 臨床化學及臨床毒理學 
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
DHA00601826108 
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 III Reagent Pack , 100 TESTS \n·1 Bottle (8.4 mL) Digoxin-Alkaline Phosphatase Conjugate in TRIS buffer with protein stabilizers. Minimum concentration: 0.05 μg/mL.\nPreservatives: sodium azide and antimicrobial agents. (Reagent Bottle 1)\n·1 Bottle (6.3 mL) Anti-digoxin (Rabbit) Coated Microparticles in TRIS buffer with protein stabilizers. Minimum concentration: 0.0001%. Preservative: sodium azide. (Reagent Bottle 2)\n·1 Bottle (27.0 mL) MEIA Buffer containing 0.3M sodium chloride in TRIS buffer. Preservatives: sodium azide and antimicrobial agents. (Reagent Bottle 3)\n·1 Bottle (41.9 mL) Digoxin III Probe Wash Solution containing 2.0M sodium chloride and detergent. Preservative: sodium azide. (Reagent Bottle 4)\n\nAxSYM Digoxin III Calibrators \n·6 Bottles (6 mL A, 4 mL each B-F) of AxSYM Digoxin III Calibrators contain digoxin prepared in recalcified human plasma, the following concentrations:
1 Bottle Digoxin Concentration \n (ng/mL) (nmol/L)\nCAL A 0.0 0.00\nCAL B 0.5 0.64\nCAL C 1.0 1.28\nCAL D 2.0 2.56\nCAL E 3.0 3.84\nCAL F 4.0 5.12\n\nAxSYM Digoxin III Controls \n·3 Bottles (8 mL each) of AxSYM Digoxin III Controls contain digoxin prepared in recalcified human plasma, the following concentration ranges:\n\nBottle Digoxin Concentration Range\n (ng/mL) (nmol/L) (ng/mL) (nmol/L)\nCONTROL L 0.9 1.15 0.60 - 1.20 0.77 - 1.54\nCONTROL M 1.9 2.43 1.43 - 2.38 1.83 - 3.05\nCONTROL H 3.2 4.10 2.50 - 3.90 3.20 - 4.99\n