適應症
檢測血清中游離甲狀腺素濃度的量。  
劑型
 
包裝
CA1535A: 100tests/kitCA1555A: 500tests/kit 
許可證字號
衛部藥製字第016057號 
註銷狀態
註銷日期
2018-05-25  
註銷理由
838 
有效日期
2016-02-27  
發證日期
2006-02-27  
許可證種類
09 
中文品名
伽瑪塗層游離甲狀腺素(二階段) 碘125競爭性放射免疫分析套組 
英文品名
GammaCoatTM Free T4 (Two-Step) 125I RIA Kit 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
新科化實業有限公司  
申請商地址
台北市中正區忠孝西路一段50號18樓之2 
通關簽審文件編號
DHAS0601605707 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIASORIN INC. 1951 NORTHWESTERN AVE. P. O. BOX 285 STILLWATER, MN U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 [125I] Thyroxine Tracer: liquid reagent Each vial contains approximately 5 &micro;Ci tracer (<1 &micro;g/mL T4) in 10 mL of tris buffered saline with 0.1% sodium azide as a preservative.Rabbit Anti-T4 Serum Coated Tubes: 12 x 75 mm tubes are coated with rabbit anti-T4 serum (titer <1 &micro;g/tube) and packaged in a plastic bag. T4 Reagent Buffer Concentrate (11X): Each vial contains 10 mL of tris buffered saline, 4 mM ANS, 6 mM sodium salicylate with 0.2% sodium azide as a preservative.T4 Serum Calibrators: Each vial contains L-thyroxine in 1 mL of processed human serum with 0.1% sodium azide as a preservative. Calibrators are provided at the following Total T4 concentrations: 1, 4, 8, 12 & 20 &micro;g/dL, respectively. Incubation Buffer: Each vial contains 125 mL of tris buffered saline with 0.1% sodium azide as a preservative.Auxiliary Labels For tracer-buffer reagentT4 Serum Calibrator:Each vial contains L-thyroxine in 1 mL of processed human serum with 0.1% sodium azide as a preservative. The optional calibrator is calibrated a