適應症
為定量人類血清或血漿檢體中TSH濃度所設計的放射免疫分析法。  
劑型
 
包裝
#07-294102: 100 Tubes 
許可證字號
衛部藥製字第016289號 
註銷狀態
註銷日期
2023-08-15  
註銷理由
838 
有效日期
2021-04-04  
發證日期
2006-04-04  
許可證種類
09 
中文品名
馬丁彼得甲狀腺刺激激素診斷套組 
英文品名
MP TSH CT 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
普生股份有限公司  
申請商地址
新竹縣寶山鄉新竹園區創新一路6號 
通關簽審文件編號
DHAS0601628902 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
MP Biomedicals Diagnostics Division 29525 Fountain Parkway, Cleveland, OH 44139, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 ANTI-HUMAN THYROID STIMULATING HORMONE COATED TUBES These tubes are coated with an antibody having a high affinity for human thyroid stimulating hormone. hTSH STANDARDS Eight standards in a horse serum based matrix containing sodium azide and gentamicin sulfate are provided at the following concentrations: 0, 0.2, 0.5, 1, 5, 10, 25 and 50 μIU/mL referenced against the WHO 1st IRP 68/38. WASH DILUENT (10X) A phosphobuffered saline diluent containing Tween is supplied in a 10X concentrated form. ANTI-hTSH 125I This is an antibody labeled with 125I and generated against a different epitope of the hTSH molecule than the antibody bound to the tube. It is provided in a phosphobuffered saline diluent containing sodium azide as a preservative.