適應症
定量測量血清或血漿中發爾波克的濃度。  
劑型
 
包裝
#6801710: 50 tests x 6#6801697: 5 ml x 1, 2 ml x 5 
許可證字號
衛部藥製字第015982號 
註銷狀態
註銷日期
2018-08-14  
註銷理由
838 
有效日期
2016-02-13  
發證日期
2006-02-13  
許可證種類
09 
中文品名
維特司生化產品發爾波克試劑 
英文品名
Vitros Chemistry Products VALP 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
DHA00601598203 
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 VALP Reagent (#6801710) containing: Reactive Ingredients Reagent 1 (R1): Mouse monoclonal antibodies reactive to valproic acid 30,125 pg/mL; nicotinamide adenine dinucleotide (NAD) 18 mM; glucose-6-phosphate (Na-G6P) 22 mM Reagent 2 (R2): Valproic acid labeled with glucose-6-phosphate dehydrogenase (G6P-DH, EC 1.1.1.49, from Leuconostoc mesenteroides) 0.57 pg/mL Other Ingredients Reagent 1 (R1): Inorganic salt, organic salt, proteins, protease inhibitor, stabilizer, surfactant, preservative, displacing agent Reagent 2 (R2): Buffers, inorganic salt, organic salt, proteins, protease inhibitor, biological material (mouse monoclonal antibody), preservatives VITROS Chemistry Products Calibrator Kit 12(#6801697) is an aqueous solution containing valproic acid, buffer, inorganic salt, stabilizers and preservatives.Nominal Values Used for the Manufacture of VITROS Chemistry Products Calibrator Kit 12
1 Analyte Calibrator Vial Units Calibrator Vial Units\n 1 2 3 4 5 6 1 2 3 4 5 6 \nVALP 0 10 25 50 100 150 mg/mL 0 69 173 347 693 1040 mmol/L\n