埃達堤斯抗核體篩檢
Adaltis EIAgen ANA screen

適應症
以酵素連結免疫吸附分析法(enzyme-linked immunosorbent assay method, ELISA)，針對人類血清中，抗核抗原的特定IgG自體抗體做定量之用。  
劑型
 
包裝
#112901GC: 96 Tests 
許可證字號
衛部藥製字第017891號 
註銷狀態
1 
註銷日期
2014-04-16  
註銷理由
838 
有效日期
2012-01-25  
發證日期
2007-01-25  
許可證種類
09 
中文品名
埃達堤斯抗核體篩檢 
英文品名
Adaltis EIAgen ANA screen 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
美艾利爾健康股份有限公司  
申請商地址
臺北市松山區南京東路4段16號11樓 
通關簽審文件編號
DHA00601789100 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ADALTIS ITALIA SPA VIA LUIGI EINAUDI, 7-00012 GUIDONIA MONTECELIO (RM), ITALY IT
ADALTIS ITALIA S.P.A. VIA CRISTONI, 12, 40033 CASALECCHIO DI RENO, BOLOGNA (BO), ITALY IT
成份表
處方標示 成分名稱 含量 單位
1 KIT COMPONENTSMICROPLATE (code 45PIA)1 microplate is supplied which contains 12 strips of 8 breakapart wells. The wells are coated Hep-2 extract containing the ANA antigens.CONJUGATE (code 45HRP)1 vial containing 15ml of ready-to-use HRP conjugate.CALIBRATORS4 vials containing 1ml of calibrator. The calibrators are calibrated to WHO 66/233 Anti-Nuclear Factor (ANF) International Units and contain human antisera.POSITIVE CONTROL (code 45POS)1 vial containing 0.45ml of concentrated positive control which contains human antisera.
1 NEGATIVE CONTROL (code 45NEG) 1 vial containing 0.45ml of concentrated negative control which contains normal human serum.SUBSTRATE (TMB) (code 45 TMB)1 vial containing 15ml of ready-to-use tetra-methylbenzidine (TMB) substrate.SAMPLE DILUENT (code 45SD)2 bottles containing 60ml/each of ready-to-use sample diluent buffer.WASHING BUFFER conc 20X (code TLAVC)1 bottle containing 50ml of wash buffer concentrate. Wash buffer concentrate contains 0.02% thimerosal.STOP SOLUTION (code STOPC)1 bottle containing 20ml of 0.25M H2SO4 stop solution.