適應症
定量偵測人類血清及血漿中人類甲狀腺刺激素的量。  
劑型
 
包裝
2 x 50 Tests/Kit 
許可證字號
衛部藥製字第012088號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-08-18  
發證日期
2005-08-18  
許可證種類
09 
中文品名
貝克曼庫爾特亞瑟斯超敏感人類甲狀腺刺激素試劑 
英文品名
BECKMAN COULTER Access HYPERsensitive hTSH 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
DHA00601208803 
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 HYPERsensitive hTSH Reagent: 100 determination, 2 packs, 50 tests/pack R1a: Paramagnetic particles coated with goat anti-mouse IgG: mouse monoclonal anti-hTSH complexes suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA), <0.1% sodium azide, and 0.1% ProClin300R1b: TRIS buffered saline with surfactant, BSA, protein (murine, goat), <0.1% sodium azide, and 0.1% ProClin300R1c: Goat anti-hTSH-alkaline phosphatase (bovine) conjugate in TRIS buffered saline, with surfactant, BSA, protein(goat), <0.1% sodium azide, and 0.1% ProClin300Access HYPERsensitive hTSH Calibrators: S0-S5, 4.0mL/vialS0: Buffered bovine serum albumin (BSA) matrix with surfactant, <0.1% sodium azide, and 0.5% ProClin 300.Contains 0.0 ulU/mL (mlU/L) hTSHS1、S2、S3、S4、S5:Approximately 0.1, 0.5, 4.0, 10.0 and 100.0 ulU/mL(mlU/L)hTSH, respectively, in buffered BSA matrix with surfactant, <0.1% sodium azide, and 5% ProClin300