適應症
定量測量血清中總鐵結合能力的濃度。  
劑型
 
包裝
#6802001 
許可證字號
衛部藥製字第016801號 
註銷狀態
註銷日期
2018-08-14  
註銷理由
838 
有效日期
2016-05-22  
發證日期
2006-05-22  
許可證種類
09 
中文品名
維特司生化產品直接總鐵結合能力試劑 
英文品名
Vitros Chemistry Products dTIBC Reagent 
藥品類別
A 臨床化學及臨床毒理學 
申請商地址
臺北市內湖區堤頂大道2段407巷20弄1、3、5、7號10樓,及22、24、26號10樓及22號10樓之1 
通關簽審文件編號
DHA00601680104 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ORTHO-CLINICAL DIAGNOSTICS, INC. 1000 LEE ROAD, ROCHESTER, NEW YORK, 14606, U.S.A. US
ORTHO-CLINICAL DIAGNOSTICS, INC 100 INDIGO CREEK DRIVE, ROCHESTER, NEW YORK 14626-5101, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Vitros Chemistry Products dTIBC Reagent (6802001) containing: Reactive IngredientsReagent 1 (R1): Chromazurol B 166 µmol/L (0.008% w/v); Cetrimide 735 µmol/L (0.03% w/v); Acetic Acid 250 mmol/L; Ferric Chloride Hexahydrate 16 µmol/L (0.0004% w/v)Reagent 2 (R2): Sodium Bicarbonate 338 mmol/L (2.8% w/v)Other IngredientsReagent 1 (R1): Preservative, copper chelator and stabilizersReagent 2 (R2): Buffer and preservative Vitros Chemistry Products Calibrator Kit 29 (6802344): Calibrator Level 1 is an aqueous solution containing processed bovine serum albumin, and preservative. Calibrator Level 2 is a lyophilate containing processed human serum, proteins, enzymes, organic compounds, electrolytes, immunoglobulins, inorganic compounds, hormones, and metals.
1 Vitros Chemistry Products dTIBC Performance Verifiers I and II (6802348, 6802349) Verifiers are prepared from processed human serum to which enzymes, electrolytes, stabilizers, preservatives, and other organic analytes have been added. Vitros Chemistry Products FS Reconstitution Diluent (6801874) is prepared from processed water.