"西門子" 複合前列腺特異性抗原試劑
ADVIA Centaur cPSA

適應症
用於體外診斷，利用ADVIA® CentaurTM系統定量人血清中的cPSA(複合前列腺特異性抗原)。  
劑型
 
包裝
#06684007 (124830): 100tests#09702804 (125308): 1x5mL pretreatment#02614268 (125014): 2x2mL low calibrator2x2mL high calibrator#02508026 (125425): 1x2mL Level 1, 1x2 mL Level 2, 1x2 mL Level 3 
許可證字號
衛部藥製字第017317號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2026-09-07  
發證日期
2006-09-07  
許可證種類
09 
中文品名
"西門子" 複合前列腺特異性抗原試劑 
英文品名
ADVIA Centaur cPSA 
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
DHA00601731704 
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
成份表
處方標示 成分名稱 含量 單位
1 Lite reagent: polyclonal goat anti-PSA antibody (~77 ng/mL) labeled with acridinium ester in buffered saline with bovine serum albumin and preservatives \nSolid phase: monoclonal mouse anti-PSA antibody (~25μg/mL) covalently coupled to paramagnetic particles in buffered saline with bovine serum albumin and preservatives\nPretreatment: free-PSA-specific monoclonal mouse anti-PSA antibody (~50μg/mL) in buffered saline with bovine serum albumin and preservatives \nCalibrator: after reconstitution, low or high levels of complexed PSA in goat serum with sodium azide (<0.1%) and preservatives \nQC: after reconstitution, various levels of complexed PSA in goat serum with sodium azide (<0.1%) and preservatives \n