適應症
測定人類血清中水痘-帶狀皰疹IgG抗體的定性方法。  
劑型
 
包裝
#081075 (48 Tests)#081014 DS (96 Tests) 
許可證字號
衛部藥製字第016514號 
註銷狀態
註銷日期
2012-11-06  
註銷理由
838 
有效日期
2011-05-02  
發證日期
2006-05-02  
許可證種類
09 
中文品名
埃達堤斯水痘帶狀皰疹病毒IgG 
英文品名
Adaltis EIAgen Varicella Zoster IgG 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
臺北市松山區南京東路4段16號11樓 
通關簽審文件編號
DHA00601651401 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ADALTIS ITALIA S.P.A. VIA CRISTONI, 12, 40033 CASALECCHIO DI RENO, BOLOGNA (BO), ITALY IT
成份表
處方標示 成分名稱 含量 單位
1 MICROPLATE:6X2 strips coated with Varicella Zoster virus.CONJUGATE:anti-human IgG monoclonal antibodies labelled with Peroxidase, in phosphate buffer solution containing phenol 0.05% and Bronidox 0.02%. Ready for use whitout further dilution.POSITIVE CONTROL:Diluted human serum containing anti-Varicella zoster IgG, in Phosphate buffer 0.01 mol/L containing BSA.CONTROL CUT OFF:Diluted human serum containing anti-Varicella zoster IgG in Phosphate buffer 0.01 mol/L containing BSA 1% and sodium azide 0.09%, liquid, ready for use without further dilution. NEGATIVE CONTROL:Human serum not containing anti-Varicella zoster IgG, in Phosphate buffer 0.01 mol/L, with BSA 1% and sodium azide 0.09%, liquid, ready for use without further dilution. SUBSTRATE:Contains: Tetramethylbenzidine 0.26 mg/mL and hydrogen peroxide 0.01% stabilized in citrate buffer 0.05 mol/L (pH 3.8). DILUENT 50X:Protein solution conc. 50X with added phenol 0.05% and Bronidox 0.02%WASH BUFFER 10X:Phosphate buffered saline, concentrated 10 tim