適應症
對人類血清中以酵素免疫法定性測定對抗細胞巨大性病毒的免疫球蛋白M。  
劑型
 
包裝
#72681: 96 Tests 
許可證字號
衛部藥製字第016285號 
註銷狀態
註銷日期
2012-11-06  
註銷理由
838 
有效日期
2011-03-31  
發證日期
2006-03-31  
許可證種類
09 
中文品名
伯樂亞 細胞巨大性病毒 免疫球蛋白M 
英文品名
Platelia CMV IgM 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
台北市松山區南京東路4段126號14樓 
通關簽審文件編號
DHA00601628502 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
BIO-RAD 3BD RAYMOND POINCARE 92430 MARNES-LA-COQUETTE FRANCE FR
成份表
處方標示 成分名稱 含量 單位
1 MT PLATE: 12 x 8 wells coated with anti-human IgM monoclonal antibodies.\nCONTROL + :\nDiluted human serum (containing anti-CMV IgM antibodies) in Phosphate buffer\n0.01 mol/L with BSA 1% and sodium azide 0.09%, liquid, ready for use without further\ndilution.\nCONTROL CUT OFF :\nDiluted human serum (containing anti-CMV IgM antibodies) in Phosphate buffer\n0.01 mol/L with BSA 1% and sodium azide 0.09%, liquid, ready for use without further\ndilution.\nAg :\nPartially purified Cytomegalovirus, inactivated by treatment with Betapropiolactone,\nin Phosphate buffer containing mouse ascitic fluid and lactose.\nCONJ :\nmonoclonal antibodies labelled with peroxidase, in phosphate buffer with phenol\n0.05% and Bronidox 0.02%.\nThe immunocomplex should be prepared about 45 min. before use.\nCONTROL IgM :\nDiluted human serum in Phosphate buffer 0.01 mol/L with BSA 1% and sodium\nazide 0.09%, liquid, ready for use without further dilution.\nWASH BUF 10x :\nPhosphate buffered saline, concentrated 10 times; contains Brij