"代首林" 副甲狀腺激素放射免疫分析試劑
"DiaSorin" N-tact PTH SP

適應症
定量檢測人體血清或血漿中生物活性之原態副甲狀腺素(hPTH 1-84)之含量。  
劑型
 
包裝
#26100: 100 tests 
許可證字號
衛部藥製字第015421號 
註銷狀態
1 
註銷日期
2012-11-27  
註銷理由
838 
有效日期
2010-12-10  
發證日期
2005-12-10  
許可證種類
09 
中文品名
"代首林" 副甲狀腺激素放射免疫分析試劑 
英文品名
"DiaSorin" N-tact PTH SP 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
泰歷藥品儀器股份有限公司  
申請商地址
台北市大同區承德路二段81號15樓 
通關簽審文件編號
DHAS0601542100 
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.N-tact PTH SP Calibrator 0: 1 vial 15 mL. Contains human serum with 0.1% sodium azide added as a preservative.2.N-tact PTH SP Calibrator 1-5:lyophilyzed reagent. Set of 5 human PTH 1-84 calibrators, at nominal concentrations ranging from 15-2000 pg/mL, contains 0.1% sodium azide and other stabilizers.3.N-tact PTH SP Beads: 1 container, 100 beads. Polystyrene beads are coated with affinity-purified goat antibody specific for the 39-84 sequence of PTH.4.I-125 N-tact PTH SP Antibody: 2 vials. Each vial contains 5.0 mL of affinity purified goat antibody specific for PTH 1-34, labeled with iodine-125. 5.N-tact PTH SP Wash Solution Concentrate. 1 vial, 50 mL.Contains a concentrated buffered surfactant. Prepare a working wash solution by diluting the entire vial contents with 450 mL of distilled or deionized water. 6. N-tact PTH SP Control, Level 1 and Level 2:2 vials lyophilized reagent. Human serum is spiked with hPTH 1-84 to obtain a concentration with a specified range. 0.1% sodium azide is added.