適應症
用於定量測定血清及血漿中高密度脂蛋白膽固醇的濃度。  
劑型
 
包裝
#6801895: 300 tests/kit,#6802469: 90 tests/kit 
許可證字號
衛部藥製字第016114號 
註銷狀態
註銷日期
2018-08-14  
註銷理由
838 
有效日期
2016-03-08  
發證日期
2006-03-08  
許可證種類
09 
中文品名
維特司生化產品直接高密度脂蛋白膽固醇試藥片 
英文品名
Vitros Chemistry Products dHDL slides 
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
DHA00601611401 
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. 513 TECHNOLOGY BOULEVARD, ROCHESTER, NEW YORK 14626, 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 dHDL slides :Reactive ingredients per cm2 Emulgen B-66 0.7 mg; phosphotungstic acid 0.3 mg; magnesium chloride 0.2 mg, cholesterol oxidase (Cellulomonas, E.C.1.1.3.6) 0.8 U; cholesterol ester hydrolase (Candida rugosa, E.C.3.1.1.3) 1.2 U; peroxidase (horseradish root, E.C.1.11.1.7) 2.2 U; and 2-(3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis-(4-dimethylaminophenyl) imidazole (leuco dye) 0.02 mg.Other ingredients Pigment, binders, buffer, surfactants, stabilizers, scavenger, and cross-linking agent.Vitros Chemistry Products Calibrator Kit 25 :The calibrators are prepared from processed human serum and purified human HDL cholesterol to which organic analytes, inorganic salts, electrolytes, stabilizers, and preservatives have been added. The diluents are prepared from processed water to which a preservative has been added.Nominal Values Used for the Manufacture of VITROS Chemistry Products Calibrator Kit 25*\nAnalyte CalibratorVial 1 CalibratorVial 2 CalibratorVial 3 Units CalibratorVial 1 Cali