“恩奈格斯特”單純皰疹病毒IgM抗體 檢驗試劑
Enzygnost Anti-HSV/IgM

適應症
定性及定量檢測人類血清與血漿中單純皰疹病毒(HSV)之特異性IgM抗體的酵素免疫分析法。  
劑型
 
包裝
OWNX：2x48 tests 
許可證字號
衛部藥製字第020755號 
註銷狀態
1 
註銷日期
2021-03-04  
註銷理由
841 
有效日期
2019-12-21  
發證日期
2009-12-21  
許可證種類
09 
中文品名
“恩奈格斯特”單純皰疹病毒IgM抗體 檢驗試劑 
英文品名
Enzygnost Anti-HSV/IgM 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
西門子醫療設備股份有限公司  
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
DHA00602075502 
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-HSV/lgM Test Plate: with deactivated HSV antigen-coated microtitration plate.The left row of a strip contains antigen from HSV-infected permanent monkey kidney cells, and the right row contains antigen from uninfected cells (= control antigen).\n\nAnti-Human-IgM/POD Conjugate: Goat antibodies to human IgM, conjugated with peroxidase in\n0.05 mol/L Tris/HCl Buffer Solution, pH 7.2, with polygeline 0.5 %. The conjugate is red colored.\nDye: approximately 400 mg/L Brilliant Ponceau.\nPreservative: maximum 1 g/L phenol.\n\nConjugate Buffer Microbiol: 37 mg/L EDTA in 0.01 molar phosphate buffer solution, pH 7.2,with Tetronic, approximately 2 %, BSA approxirnately 1 %.\nPreservatives: approximately 100 mg/L gentamicin,\napproximately 6 mg/L 5-chloro-2-methyl-isothiazole-3-one,\nand approximately 2 mg/L 2-methyl-4-isothiazole-3-one.\n\n
1 Anti-HSV Reference P/P: Human serum with IgG-antibodies to HSV-antigens in conjunction with\nrheumatoid factors (RF) in Tris buffer solution (20 mmol/L, pH 7.4, with Humanalbin (5 %), approximately 60 %.\nThe nominal value required for the evaluation as well as its upper and lower margins in absorbance units are listed in the barcode table of values.\nPreservatives: approximately 5 mg/L amphotericin B and approximately 100 mg/L gentamicin.\n\nAnti-HSV Reference P/N: Human serum with IgG-antibodies to HSV antigens in Tris buffer solution (20 mmol/L), pH 7.4, with Humanalbin (5 %), approximately 60 %.\nPreservatives: approximately 5 mg/L amphotericin B and approximately 100 mg/L gentamicin.\n\n
1 Sample Buffer POD: 0.3 mol/L Tris/HCl buffer solution, pH 8.0 - 8.2, with Tween 20 approximately 0.1 %, polygeline approximately 1 %, bovine serum approximately 5 %.\nPreservatives: approxirnately 5 mg/L amphotericin B and approximately 100 mg/L gentamicin.\n\nRF-Absorbent (lyophilized): Sheep antibodies targeted against human IgG-Fc fragment in phosphate buffered (10 mmol/L.) , p.H 7.2, saline solution (8.2 g/L).\nPreservative: Sodium azide (maximum 0.4 g/L).\n