適應症
提供血清或血漿完整PTH(I-PTH)的定量測定。  
劑型
 
包裝
DSL-8000-5: 500 testsDSL-8000: 100 tests 
許可證字號
衛部藥製字第015947號 
註銷狀態
註銷日期
2012-11-26  
註銷理由
838 
有效日期
2011-01-25  
發證日期
2006-01-25  
許可證種類
09 
中文品名
常盈完整副甲狀腺激素試劑組 
英文品名
DSL INTACT PTH IRMA 
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
DHAS0601594709 
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 I-PTH Standards:\nOne vial, 5 mL, labeled A, containing 0 pg/mL I-PTH and six vials, 1 mL each, labeled B-G, containing\napproximate concentrations of 10, 30, 100, 250, 750 and 2000 pg/mL human PTH (1-84) in a protein-based\nbuffer with a non-mercury preservative.\n* DSL-8000 (500 Tubes) contains three sets of standards\nAnti-PTH-Coated Tubes: \nOne hundred (100) plastic tubes with Anti-PTH (39-84) immobilized to the inside wall of each tube. \n* DSL-8000 (500 Tubes) contains five hundred (500) plastic tubes.\n
1 Anti-PTH [I-125] Reagent: \nTwo vials in DSL-8000 (100 Tubes) , 5.5 mL each, containing <10 μCi (370 kBq) per vial of [I-125]-labeled\nanti-PTH (1-34) in a protein-stabilized buffer and sodium azide as a preservative. \n* DSL-8000 (500 Tubes) contains ten (10) vials of reagent.\nI-PTH Controls:\nTwo vials containing low and high concentrations of I-PTH in a protein-based buffer with a non-mercury\npreservative.\n* DSL-8000 (500 Tubes) contains three sets of controls.\nWash Concentrate:\nOne bottle, 100 mL, containing buffered saline with a nonionic detergent. \n* DSL-8000 (500 Tubes) contains five bottles of wash concentrate.\n