適應症
鑑定對血清中黴漿菌的IgM抗體。  
劑型
 
包裝
#081040: 96 tests 
許可證字號
44003176 
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
埃達堤斯肺炎黴漿菌病毒IgM 
英文品名
Adaltis EIAgen Mycoplasma pneumoniae 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
DHA04400317606 
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 Microtiterstrips: The wells are coated with purified, inactive antigen.\nPeroxidase Conjugate: Sheep anti-human IgM peroxidase conjugate contains 0.049% thimerosal.\nPositive Control: Positive control which contains 0.095% sodium azide as a preservative.\nNegative Control: Negative control which contains 0.095% sodium azide as a preservative.\nCutoff Control: Cutoff control which contains 0.095% sodium azide as a preservative.\nTMB Substrate: tetra-methylbenzidine (TMB) substrate.\nSample Diluent: sample diluent buffer. The buffer includes 0.05% microbial preservative.\nWash Solution 25X: containing 80 ml of wash solution concentrate.\nStop Solution: containing 15 ml of 0.95N H2SO4 stop solution.\n