"西門子" 恩奈格斯特 麻疹病毒IgM抗體 檢驗試劑組 (未滅菌)
"Siemens" Enzygnost Anti-Measles-Virus/IgM (non-sterile)

適應症
定性和定量檢測人類血清和血漿中麻疹病毒之特異性IgM抗體的酵素免疫分析法。  
劑型
 
包裝
空白 
許可證字號
44000466 
註銷狀態
1 
註銷日期
2022-07-15  
註銷理由
851 
有效日期
2020-09-15  
發證日期
2005-09-15  
許可證種類
09 
中文品名
"西門子" 恩奈格斯特 麻疹病毒IgM抗體 檢驗試劑組 (未滅菌) 
英文品名
"Siemens" Enzygnost Anti-Measles-Virus/IgM (non-sterile) 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
開榮股份有限公司  
申請商地址
台北市松山區塔悠路81號6樓之1 
通關簽審文件編號
DHA04400046600 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH EMIL-VON-BEHRING-STRABE. 76, D-35041 MARBURG, GERMANY DE
成份表
處方標示 成分名稱 含量 單位
1 1.Enzygnost® Anti-Measles Virus/IgM, test plate: Microtitration plate coated with inactivated measles virus antigen. The wells in the left row of each strip are coated with antigen derived from permanent simian kidney cells infected with measles virus, and the wells in the right row are coated with non-infected cells (=control antigen). 2.Anti-Human IgM/POD Conjugate: Goat antibodies to human IgM, conjugated with peroxidase and contained in 0.05 molar Tris/HCl buffer solution, pH 7.2, with 0.5% polygeline. The conjugate is coloured red.Dye: approx. 400 mg/L Brilliant Ponceau.Preservative: max. 1g/L phenol.3.Conjugate Buffer Microbiol: 37 mg of EDTA in a litre of 0.01 molar phosphate-buffered solution, pH 7.2, with approx. 2% Tetronic® and approx and approx. 1% BSA.Preservatives: approx. 100 mg/L gentamicin, approx. 6 mg/lL5-chloro-2-methyl-isothiazole-3-one and approx. 2 mg/L 2-methyl-isothiazole-3-one4.Anti-Measles Virus Reference P/P: Human serum containing IgG antibodies to mea