適應症
利用一化學冷光微粒酵素免疫分析法(CMIA),可定量測試人類血清或血漿中的心肌肌鈣蛋白。  
劑型
 
包裝
#2K41G,#2K41J,#2K41H,#2K41L,#2K41M,#2K41N,#2K41A,#2K41B,#2K41C,#2K41D,#2K41E,#2K41F,#2K41,#2K41-01,#2K41-30,#2K41-25,#2K41-10, 以下空白。 
許可證字號
衛部藥製字第013403號 
註銷狀態
註銷日期
2012-11-06  
註銷理由
838 
有效日期
2010-10-31  
發證日期
2005-10-31  
許可證種類
09 
中文品名
亞培設計師心肌肌鈣蛋白-I檢驗試劑組 
英文品名
ABBOTT ARCHITECT STAT Troponin-I 
藥品類別
A 臨床化學及臨床毒理學用裝置 
申請商地址
台北市中山區民生東路三段49號5、6樓及51號5、6樓 
通關簽審文件編號
DHA00601340303 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ABBOTT LABORATORIES 100/200 ABBOTT PARK ROAD, ABBOTT PARK, ILLINOIS 60064, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 ARCHITECT STAT Troponin-I Reagent Pack:\nMICROPARTICLES: Anti-tropnin-I\n(mouse, monoclonal) coated microparticles in TRIS buffer with protein\n(bovine and goat) stabilizers\nCONJUGATE: Anti-tropnin-I (mouse. Monoclonal) acridinium labeled conjugate in MES buffer with protein (bovine) stabilizer.\nASSAY DILUENT: Tropnin-I Assay Diluent contains protein (bovine and goat) stabilizers in phosphate buffer.\nARCHITECT STAT Troponin-I Calibrators:\nCalibrator A contains human serum, nonreactive for HBsAg. HIV-1 Ag or HIV-1 NAT. anti-HCV. and anti-HIV-1/HIV-2.\nPreservative: Sodium Azide. Calibrators B through F contain a recombinant human cardiac troponin IC complex in phosphate buffer with protein (bovine) stabilizer.\nARCHITECT STAT Troponin-I Controls:\ncontain a recombinant human cardiac troponin IC complex in BES buffer with protein (fish and human [donor units of which have been tested and found to be nonreactive for HBsAg. HIV-1 Ag or HIV-1 NAT. anti-HCV. and anti-HIV-1/HIV-2.])\n \n \n