適應症
本產品用以定量檢測人體完整 (Whole PTH) 和總原態副甲狀腺激素 (Total intact PTH) 的含量。  
劑型
 
包裝
3KG601 
許可證字號
衛部藥製字第018952號 
註銷狀態
註銷日期
2019-12-20  
註銷理由
851 
有效日期
2018-02-13  
發證日期
2008-02-13  
許可證種類
09 
中文品名
“詩干地巴底”副甲狀腺激素放射免疫分析試劑組 
英文品名
“Scantibodies”Duo PTH Kit 
藥品類別
A 臨床化學及臨床毒理學 
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
DHAS0601895204 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY, SANTEE, CA 92071, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 1.PTH Calibrators: 7 vials each for Whole PTH and 7 vials each for Total Intact PTH containing lyophilized human serum with normal synthetic PTH and sodium azide 0.1% (w/v).\n2.PTH Controls: 2 vials each for Whole PTH and 2 vials each for Total Intact PTH containing synthetic PTH in lyophilized human serum with 0.1% (w/v) sodium azide.\n3.125I-Anti N-Terminal PTH Tracer: 2 bottles of affinity purified goat anti N-terminal PTH 125I-antibodies in 5 ml phosphate buffered saline with sodium azide 0.1% (w/v) and protein stabilizer. Maximum radioactivity is <370 kBq (<10 μCi).
1 4.Total Intact PTH Tracer: 2 bottles of affinity purified goat anti-PTH (1-34) 125I-antibodies in 5 ml phosphate buffered saline with sodium azide 0.1% (w/v) and protein stabilizer. Maximum radioactivity is <370 kBq (<10 μCi).\n5.PTH (39-84) Antibody Coated Beads: 2 bottles of 100 polystyrene beads, each plus desiccant contains silica. Beads are coated with affinity purified goat anti-PTH (39-84).\n6.Wash Concentrate: 2 bottles of 30 ml each of a 30 fold concentrate of phosphate buffered saline with sodium azide 1.5% (w/v) and detergent.