適應症
利用放射性免疫定量方法檢測血清中總三碘甲狀腺素荷爾蒙。  
劑型
 
包裝
DSL-3100 (100 tubes)、DSL-3100-5 (500 tubes) 
許可證字號
衛部藥製字第015866號 
註銷狀態
註銷日期
2012-11-26  
註銷理由
838 
有效日期
2011-01-11  
發證日期
2006-01-11  
許可證種類
09 
中文品名
常盈總三碘甲狀腺素檢驗試劑 
英文品名
DSL T3 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
DHAS0601586609 
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 T3 Standards:One vial, 1.0 ml, labeled A, containing 0 ng/dL and six vials, 0.5 mL each, labeled B-G, containing concentrations of approximately 25.0, 50.0, 100.0, 250.0, 500.0 and 1000.0 ng/dL T3 in huamn serum with sodium azide as a preservative.*DSL-3100 (500 Tubes) contains 3 sets of Standards. T3 [I-125] Reagent:One bottle in DSL-3100 (100 Tubes), 22 mL each, containing < 5 μCi (185 kBq) of [I-125]-labeled T3 in a protein-based (BSA) buffer with sodium azide as a preservative.*DSL-3100 (500 Tubes) contains five bottles of reagent. GAMG-Coated Tubes:One hundred (100) plastic tubes with goat anti-mouse gamma globulin immobilized to the inside wall of each tube.*DSL-3100 (500 Tubes) contains 500 tubes.
1 Anti-T3 Antibody:One vial in DSL-3100 (100 Tubes), 11 mL each, containing anti-T3 mouse monoclonal antibody in a protein-based (BSA) buffer with sodium sodium azide as a preservative.*DSL-3100 (500 Tubes) contains five vials of antibody.T3 Controls:Two vials, 0.5 mL each, Level I and II, containing low and high concentrations of T3 in human serum with sodium azide as a preservative.Wash Concentrate: One bottle, 18 mL in DSL-3100 (100 Tubes), containing a concentrated buffered saline solution with sodium azide as preservative. *DSL-3100 (500 Tubes) contains one 90 mL-bottle of wash concentrate.