適應症
定性檢測和定量測定人類血清和血漿中帶狀泡疹病毒特異性IgM抗體的酵素免疫分析法。  
劑型
 
包裝
#|OWL 15: 2×48 Test/kit 
許可證字號
衛部藥製字第013315號 
註銷狀態
註銷日期
2021-03-04  
註銷理由
851 
有效日期
2020-10-27  
發證日期
2005-10-27  
許可證種類
09 
中文品名
"恩奈格斯特" 帶狀泡疹病毒 IgM抗體 檢驗試劑組 
英文品名
"Enzygnost" Enzygnost Anti-VZV/IgM 
藥品類別
C 免疫學及微生物學用裝置 
申請商地址
臺北市南港區園區街3號2樓之2 
通關簽審文件編號
DHA00601331506 
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-STR. 76, D-35041 MARBURG, GERMANY DE
成份表
處方標示 成分名稱 含量 單位
1 Enzygnost* Anti-VZV/igM Test Plate: microtitration plate coated with inactivated VZV-antigens The left row of a strip contains antigen from VZV infected human fibroblasts and the right row contains antigen from uninfected cells (=control antigen). \nAnti-Human-IgM/POD Conjugate: Goat antibodies to human IgM conjugated with peroxidase in 0.05 mo/L Tris/HCl Buffer solution, pH 7.2, with polygeline 0.5%.\nConjugate Buffer Microbiol: 37 mg EDTA in one liter of 0.01 mol/L phosphate buffer solution, pH 7.2, with Tetronic, approximately 2%, BSA approximately 1%. \nAnti-VZV Reference P/P: Human serum with IgG-antibodies to VZV-antigens in conjunction with rheumatoid factors (RF) in Tris buffer solution (20 mmol/L), pH 7.4, with HUmanalbin (5%), approximately 60%. \nAnti-VZV Reference P/N: Human serum with IgG-antibodies to VZV-antigens in Tris buffer solution (20 mmol/L), pH 7.4, with Humanalbin (5%), approximately 60%. \nSample Buffer POD 0.3 mol/L Tris/HCl buffer solution, pH 8.0-8.2, with Tween 20 approximately 0.