適應症
定量偵測人類血清及血漿中心肌旋轉蛋白I的量,以幫助判斷心肌梗塞或心臟方面的疾病。  
劑型
 
包裝
試劑#33340: 2×50Tests/Kit校正液#33345: 6×1 mL品管液#33349: 6×2.5mL,每個濃度各2瓶 
許可證字號
衛部藥製字第012263號 
註銷狀態
註銷日期
2018-08-09  
註銷理由
851 
有效日期
2015-09-08  
發證日期
2005-09-08  
許可證種類
09 
中文品名
貝克曼庫爾特 亞瑟斯高精確度心肌旋轉蛋白I 試劑組 
英文品名
BECKMAN COULTER Access AccuTnI Reagent 
藥品類別
A 臨床化學及臨床毒理學用裝置 
申請商地址
台北市大安區敦化南路二段216號8樓 
通關簽審文件編號
DHA00601226308 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
BECKMAN COULTER INC. (IMMUNODIAGNOSTIC DEVELOPMENT CENTER) 1000 LAKE HAZELTINE DRIVE, CHASKA, MN 55318-1084, U.S.A. US
BECKMAN COULTER, INC. 4300 N. HARBOR BOULEVARD, FULLERTON, CA 92835, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Access AccuTnI ReagentR1a: Paramagnetic particles coated with mouse monoclonal anti-human cardiac tropnin I (cTnI) suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA) matrix, <0.1% sodium azide, and 0.1% ProClin 300. R1b: 0.1 N NaOHR1c: Mouse monoclonal anti-human cTnI alkaline phosphatase conjugate diluted in ACES buffered saline, with surfactant, BSA matrix, protein (bovine, goat, mouse), <0.1% sodium azide, and 0.25% ProClin 300. Access AccuTnI CalibratorsS0: Buffered bovine serum albumin (BSA) matrix with surfactant <0.1% sodium azide, and 0.1% ProClin 300.S1, S2, S3, S4, S5: Recombinant troponin complex at cTnI levels of approximately 0.3, 1.2, 5.0, 25 and 100 mg/mL (μg/L) in buffered BSA matrix with surfactant, <0.1% sodium azide, and 0.1% ProClin 300.Access AccuTnI QCQC1: Recombinant troponin complex at a cTnI level of approximately 0.5 ng/mL (μg/L) in buffered bovine serum albumin (BSA) matrix with surfactant, <0.1% sodium azide, 0.1% ProClin 300.QC2: