適應症
用於血清試驗中鑑定對血清中腮腺炎病毒的IgG抗體。  
劑型
 
包裝
#081073: 48 tests#081030 DS: 96 tests 
許可證字號
44003179 
註銷狀態
註銷日期
2012-11-06  
註銷理由
838 
有效日期
2011-03-24  
發證日期
2006-03-24  
許可證種類
09 
中文品名
埃達堤斯腮腺炎病毒IgG 
英文品名
Adaltis EIAgen Mumps IgG 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
台北市大同區塔城街64號3樓 
通關簽審文件編號
DHA04400317902 
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: strips coated with Mumps virus.\nCONJUGATE: anti-human IgG monoclonal antibodies labelled with peroxidase, in phosphate buffer solution.\nPOSITIVE CONTROL: Dilueted human serum, at known concentration of anti-Mumps IgG, in phosphate buffer 0.01 mol/l containing BSA 1% and sodium azide 0.09%.\nCONTROL CUT OFF: Diluted human serum, at known concentration of anti-Mumps IgG, in phosphate buffer 0.01 mol/l with BSA 1% and sodium azide 0.09%.\nNEGATIVE CONTROL: Human serum not containing anti-Mumps IgG, in phosphate buffer 0.01 mol/l, with BSA 1% and sodium azide 0.09%.\nSUBSTRATE: Tetramethylbenzidine and hydrogen peroxide stabilized in citrate buffer 0.05 mol/l.\nDILUENT 50X: Protein solution conc. 50x 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 0.3mol/l.\n