適應症
以放射免疫分析法定量檢測血清中甲狀腺素之濃度。  
劑型
 
包裝
#CA-1535M: 100 tests/kit#CA-1555M: 500 tests/kit 
許可證字號
衛部藥製字第016266號 
註銷狀態
註銷日期
2018-05-25  
註銷理由
838 
有效日期
2016-03-29  
發證日期
2006-03-29  
許可證種類
09 
中文品名
岱安韶韻總甲狀腺素125I放射免疫分析試劑組 
英文品名
DiaSorin Clinical Assays GammaCoat M Total T4 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
DHAS0601626603 
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 1. 125I Thyroxine Tracer Cat. No. CA-2635. 1/5 per kit. Each vial contains approximately 5 μCi tracer (<1 μg/ml T4) in 10 ml of tris buffered saline with 0.1% sodium azide as a preservative.\n2. Anti-T4 Coated Tubes (Mouse Monoclonal) Cat. No. CA-2173. 100/500 per/kit. 12 x 75 mm tubes are coated with anti-T4 mouse monoclonal antibody (titer <1 μg/tube) and packaged in a plastic bag.\n3. T4 Reagent Buffer Concentrate (11x) Cat. No. CA-2736. 1/5 per kit. Each vial contains 10 ml of tris buffered saline, 4 mM ANS, 6 mM sodium salicylate with 0.2% sodium azide as a preservative.\n4. T4 Serum Blank Cat. No. CA-2280. 1/1 per kit. Each vial contains 1 ml of processed human serum with 0.1% sodium azide as a preservative.\n5. T4 Serum Standards Cat. No. CA-2281, CA-2285.1/1 per/kit. Each vial contains L-thyroxine in 1 ml of processed human serum with 0.1% sodium azide as a preservative. Standards are provided at the following total T4 concentrations: 1, 4, 8, 12 & 20 μg/dl, respectively.\n6. Auxiliary Labels For trac