適應症
化學冷光分析法定性測試人體血清或血漿中B型肝炎核心抗原之抗體。 
劑型
 
包裝
註銷規格:Universal Wash Reagent (8389793)。 
許可證字號
衛部藥製字第011244號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-04-12  
發證日期
2005-05-02  
許可證種類
09 
中文品名
"維特司" 免疫檢驗試劑抗B型肝炎核心抗原抗體 
英文品名
VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HBC 
藥品類別
 
申請商地址
臺北市內湖區堤頂大道2段407巷20弄1、3、5、7號10樓,及22、24、26號10樓及22號10樓之1 
通關簽審文件編號
DHA00601124402 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS, PENCOED,BRIDGEND, CF35 5PZ,UNITED KINGDOM GB
成份表
處方標示 成分名稱 含量 單位
1 1 REAGENT PACK CONTAINING: .100COATED WELLS [RECOMBINANT HBCAG DERIVED FROM BACTERIA(E. COLI) COATED AT 1.5NG PER WELL]. .14.6ML ASSAY REAGENT [BUFFER WITH NEWBORN CALF SERUM, BOVINE GAMMA GLOBULINS AND ANTI-MICROBIAL AGENT 0.5% KATHON W/W)] .20.6ML CONJUGATE REAGENT (HRP-MOUSE MONOCLONAL ANTI-HBC, 0.1μG/ML, INBUFFER WITH MOUSE SERUM, HUMAN PLASMA AND ANTI-MICROBIAL AGENT(0.5 KATHON W/W). 1 CALIBRATOR PACK CONTAINING: .1 ANTI-HC CALIBRATOR (2.2ML ANTI-HBC NEGATIVE HUMAN PLASMA) WITH ANTIMICROBIAL AGENT. .LOT CALIBRATION CARD. .PROTOCOL CARD. .8 CALIBRATOR BAR CODE LABELS 1 CONTROL PACK CONTAI NING: .3 SETS OF CONTROLS 1 AND 2(HUMAN PLASMA WITH ANTIMICROBIAL AGENT), VOLUME 1.0 ML.UNIVERSAL WASH REAGENT:4.85 L BUFFER WITH ANTIMICROBIAL AGENT SIGNAL REAGENT:2 VITROS SIGNAL REAGENTS PACKS, EACH CONTAINING: .28ML BUFFER CONTAINING A LUMINOL DERIVATIVE .28ML BUFFER CONTAINING A SUBSTITUTED ACETANILIDE AND A PERACID SALT.