適應症
定量測定人類血清及血漿中的毛地黃素(digoxin)含量。  
劑型
 
包裝
#1669 DRI Digoxin Assay (25 ml,8 ml kit)。 
許可證字號
衛部藥製字第021355號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-07-19  
發證日期
2010-07-19  
許可證種類
09 
中文品名
美堅迪爾埃狄各新試劑 
英文品名
MGC DRI Digoxin Assay 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
醫全實業股份有限公司  
申請商地址
新北市新店區寶橋路235巷6弄2號9樓 
通關簽審文件編號
DHA00602135501 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
MICROGENICS CORPORATION 46500 KATO ROAD, FREMONT, CA94538, USA US
成份表
處方標示 成分名稱 含量 單位
1 Antibody Reagent Contains: monoclonal anti-digoxin antibody in a buffer solution with sodium azide as a preservative. Microparticles Reagent Contains: digoxin coated microparticles suspension in an aqueous solution with sodium azide as a preservative. Calibrators: DRI Digoxin Negative Calibrator 1 x 5 mL (Contains 5 mL buffer solution with sodium azide as a preservative); DRI Digoxin 0.5 ng/mL Calibrator 1 x 2 mL (Contains 0.5 ng/mL Digoxin in buffer solution with sodium azide as a preservative); DRI Digoxin 1.0 ng/mL Calibrator 1 x 2 mL (Contains 1.0 ng/mL Digoxin in buffer solution with sodium azide as a preservative); DRI Digoxin 2.0 ng/mL Calibrator 1 x 2 mL (Contains 2.0 ng/mL Digoxin in buffer solution with sodium azide as a preservative); DRI Digoxin 3.0 ng/mL Calibrator 1 x 2 mL (Contains 3.0 ng/mL Digoxin in buffer solution with sodium azide as a preservative); DRI Digoxin 5.0 ng/mL Calibrator 1 x 2 mL (Contains 5.0 ng/mL Digoxin in buffer solution with sodium azide as a preservative).