適應症
使用於ADVIA Centaur系統,定量測定血清或血漿中特異免疫球蛋白E(SIgE)抗體。  
劑型
 
包裝
(1) ADVIA Centaur sIgE (200 tests)(2) sIgE Calibrator (0.5 mL/vial)(3) ADVIA Centaur Allergy Screen (ALSCRN) ( 50 tests)(4) ADVIA Centaur Probe Wash 1 (12.5 mL/pack) 
許可證字號
衛部藥製字第015275號 
註銷狀態
註銷日期
2018-07-31  
註銷理由
851 
有效日期
2015-12-06  
發證日期
2005-12-06  
許可證種類
09 
中文品名
“西門子”特異免疫球蛋白E試劑組 
英文品名
ADVIA Centaur for Specific IgE (sIgE) Assay 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
西門子股份有限公司  
申請商地址
台北市南港區園區街3號8樓 
通關簽審文件編號
DHA00601527504 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
SIEMENS HEALTHCARE DIAGNOSTICS INC. 333 CONEY ST. EAST WALPOLE, MA 02032, U.S.A. US
BAYER HEALTHCARE LLC, DIAGNOSTICS DIVISION 511 BENEDICT AVENUE TARRYTOWN, NY 10591-5097 USA US
成份表
處方標示 成分名稱 含量 單位
1 產品 組成 處方\nADVIA Centaur sIgE lite reagentsolid phase lite reagent: streptavidin (~64 ug/mL) labeled with acridinium ester in buffer with HSA and sodium azide (<0.1%)solid phase: monoclonal mouse anti-human IgE antibody (62.5 ug/mL) covalently coupled to paramagnetic particles in in buffer with HSA and sodium azide (<0.1%)\nsIgE calibrator low calibratorhigh calibratorreference allergen calibrators: Birch polle (Betula verrucosa) specific IgE antibodies in human serum (High) or IgE-free human serum (Low) with sodium azide (<0.1% after recostitution)reference allergen: Biotinylated recombinant major birch pollen allergen (Bet v 1) in phosphate buffer with HAS and sodium azide (<0.1%)\nADVIA Centaur Allergy Screen (ALSCRN) lite reagentsolid phaseallergy screen reagentlow ALSCRN calibratorhigh ALSCRN calibrator lite reagent: streptavidin (~0.64 ug/mL) labeled with acridinium ester in buffer with HSA, protein stabilizers and sodium azide (<0.1%)solid phase: monoclonal mouse anti-human IgE antibody (~31.3 ug/mL) co