適應症
利用放射性免疫定量方法檢測血清中總甲狀腺素濃度。  
劑型
 
包裝
DSL-3200: 100 tubesDSL-3200-5: 500 tubes 
許可證字號
衛部藥製字第015951號 
註銷狀態
註銷日期
2012-11-26  
註銷理由
838 
有效日期
2011-01-26  
發證日期
2006-01-26  
許可證種類
09 
中文品名
常盈總甲狀腺素檢驗試劑 
英文品名
DSL Thyroxine RIA 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
常盈實業股份有限公司  
申請商地址
台北市北投區永興路一段49號 
通關簽審文件編號
DHAS0601595100 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BOULEVARD WEBSTER, TEXAS 77598 U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 T4 Standards:One vial, 2 mL, labeled A, containing 0.0 μg/dL and six vials, 0.5 mL each, labeled B-G, containing concentrations of approximately 1.0, 2.5, 5.0, 10.0, 25.0, 50.0 μg/dL T4 in serum with sodium azide as a preservative. *DSL-3200 (500 tubes) contains three sets of standards.T4 [I-125] Reagent: One bottle, 22 mL, containing < 5 μCi (185 kBq) of [I-125]-labeled T4 in a protein-based (BSA) buffer with sodium azide as a preservative. *DSL-3200 (500 Tubes) contains five bottles of reagent.Anti-T4-Coated Tubes: One hundred (100) plastic tubes with anti-T4 antibody immobilized to the inside wall of each tube. *DSL-3200 (500 Tubes) contains five (500) hundred plastic tubes.T4 Controls:Two vials, 0.5 mL each, Levels I and II, containing low and high concentrations of T4 in the euthyroid range in serum with sodium azide as a preservative. *DSL-3200 (500 Tubes) contains three sets of controls.Wash Concentrate:One bottle, 18 mL, containing buffered saline with a nonionic detergent. Dilute 50-fold with deioni