適應症
用於血清試驗中鑑定對血清中腮腺炎病毒的IgM抗體。  
劑型
 
包裝
#081074 48 Tests、#081031 DS 96 Tests 
許可證字號
44003180 
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 IgM 
英文品名
Adaltis EIAgen Mumps IgM 
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
DHA04400318000 
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:\nwells coated with antihuman IgM monoclonal antibodies.\nCONJUGATE:\nmonoclonal antibodies labelled with peroxidase, in phosphate buffer with phenol 0.05% and bronidox 0.02%. \nPOSITIVE CONTROL:\nDiluted human serum containing anti-Mumps IgM antibodies, in Phosphate buffer 0.01 mol/L with BSA 1% and sodium azide. 0.09%.\nCUT-OFF CONTROL:\nDiluted human serum containing anti-Mumps IgM antibodies, in Phosphate buffer 0.01 mol/L with BSA 1% and sodium azide 0.09%. \nIgM NEGATIVE CONTROL:\nDiluted human serum in Phosphate buffer 0.01 mol/L with BSA 1% and sodium azide 0.09%.\nSUBSTRATE:\nTetramethylbenzidine 0.26 mg/mL and hydrogen peroxide 0.01% stabilised in citrate buffer 0.05 mol/L.\nDILUENT 50X:\nProteic solution concentrated 50 times, with added phenol 0.05% and Bronidox 0.02%. \nWASH BUFFER 10X:\nPhosphate buffered saline, concentrated 10 times; contains Brij 0.5%. \nSTOP SOLUTION:\nH2SO4 0.3 mol/L. \nANTIGEN:\nPurified Mumps virus, inactivated by treatment with beta-propiolactone, in Phosphate