埃達堤斯水痘帶狀皰疹病毒IgM
Adaltis EIAgen Varicella Zoster IgM

適應症
對抗人類血清中之抗水痘-帶狀皰疹病毒之IgM抗體的定性方法。  
劑型
 
包裝
#081076: 48 tests#081015 DS: 96 tests 
許可證字號
衛部藥製字第016515號 
註銷狀態
1 
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IgM 
英文品名
Adaltis EIAgen Varicella Zoster IgM 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
美艾利爾健康股份有限公司  
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
DHA00601651503 
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
ADALTIS ITALIA SPA VIA LUIGI EINAUDI, 7-00012 GUIDONIA MONTECELIO (RM), ITALY IT
成份表
處方標示 成分名稱 含量 單位
1 MICROPLATE MT PLATE: 6 x 2 strips coated with antihuman IgM monoclonal antibodies.\nCONJUGATE: monoclonal antibodies labelled with HRP, in phosphate buffer with mouse ascetic fluid, phenol 0.05% and bronidox 0.02%\nPOSITIVE CONTROL: diluted human serum in phosphate buffer 0.01 mol/l with BSA 1% and sodium azide 0.09%, liquid\nCUT-OFF CONTROL: diluented human serum in phosphate buffer 0.01 mol/l with BSA 1% and sodium azide 0.09%, liquid\nIgM NEGATIVE CONTROL: diluent human serum in phosphate buffer 0.01 mol/l with BSA 1% and sodium azide 0.09%, liquid\nSUBSTRATE: tetramethylbenzidine 0.26 mg/ml and hydrogen peroxide 0.01% stabilized in citrate buffer 0.05 mol/l (pH 3.8)\nDILUENT 50X: proteic solution concentrated 50 times, with added phenol 0.05% and bronidox 0.02%\nWASH BUFFER 10X: phosphate buffered saline, concentrated 10 times; contains Brij 0.5%\nSTOP SOLUTION: H2SO4 0.3 mol/l in solution\nANTIGEN: partially purified Varicella Zoster virus inactivated by treatment with Beta-propiolactone, in phosphate bu