適應症
定性檢測人類血清中抗Epstein-Barr virus病毒的capsid抗原(VCA)之人類免疫球蛋白M抗體。  
劑型
 
包裝
EBVM0150: 96 WELLS/KIT 
許可證字號
44002616 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2026-02-10  
發證日期
2006-02-10  
許可證種類
09 
中文品名
諾法鐵人類抗伊斯頓-巴病毒免疫球蛋白M酵素免疫分析套組(未滅菌) 
英文品名
NovaTec ESPTEIN-BARR VIRUS (EBV-VCA) IgM (Non-Sterile) 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
新北市汐止區福德三路369號12樓 
通關簽審文件編號
DHA04400261603 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
NOVATEC IMMUNDIAGNOSTICA GMBH WALDSTRABE 23 A6, D-63128 DIETZENBACH, GERMANY DE
成份表
處方標示 成分名稱 含量 單位
1 Epstein-Barr Virus Coated Wells (IgM): 12 breakapart 8-well snap-off strips coated with Epstein-Barr Virus antigen; vacuum sealed, in resealable aluminium foil.\nIgM Sample Diluent ***: 1 bottle containing 100 ml of buffer for sample dilution; pH 7.2 ± 0.2; coloured yellow; ready to use; white cap. \nStop Solution: 1 bottle containing 15 ml sulphuric acid, 0.2 mol/l; ready to use; red cap.\nWashing Solution (20x conc.)*: 1 bottle containing 50 ml of a 20-fold concentrated buffer (pH 7.2 ± 0.2) for washing the wells; white cap.\nEpstein-Barr Virus anti-IgM Conjugate**: 1 bottle containing 20 ml of peroxidase labelled rabbit antibody to human IgG; coloured red, ready to use; black cap.\n
1 TMB Substrate Solution: 1 bottle containing 15 ml 3,3,5,5-tetramethylbenzidine (TMB); ready to use; yellow cap.\nEpstein-Barr Virus IgM Positive Control***: 1 bottle containing 2 ml; coloured yellow; ready to use; red cap.\nEpstein-Barr Virus IgM Cut-off Control***: 1 bottle containing 2 ml; coloured yellow; ready to use; green cap.\nEpstein-Barr Virus IgM Negative Control***: 1 bottle containing 2 ml; coloured yellow; ready to use; blue cap.\n* contains 0.01 % Kathon after dilution\n** contains 0.2 % Bronidox L\n*** contains 0.1 % Kathon\n