“詩干地巴底”總原態副甲狀腺激素放射免疫分析試劑(標幟試管)
“Scantibodies”Total Intact PTH (Coated Tube)

適應症
本產品用於定量檢測血液檢體之總原態副甲狀腺素激素(Total Intact PTH)的含量。  
劑型
 
包裝
# 3KG013 (100 tubes) 
許可證字號
衛部藥製字第018273號 
註銷狀態
1 
註銷日期
2019-12-20  
註銷理由
851 
有效日期
2017-05-28  
發證日期
2007-05-28  
許可證種類
09 
中文品名
“詩干地巴底”總原態副甲狀腺激素放射免疫分析試劑(標幟試管) 
英文品名
“Scantibodies”Total Intact PTH (Coated Tube) 
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
DHAS0601827300 
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：One set of calibrators consists of seven vials containing lyophilized human serum with nominal PTH concentration.\n2.PTH Controls：One set of controls consists of two vials containing PTH in lyophilized human serum with 0.1% (w/v) sodium azide.\n3.Total Intact PTH tracer：One set of tracer consists of two bottles of I-125-anti PTH (1-34). Each bottle contains polyclonal goat anti PTH (1-34) which is labeled with I-125 and dissolved in 5 ml phosphate buffered saline with sodium azide 0.1% (w/v) and protein stailizers. The maximum radioactivity in a bottle is＜370 kBq (＜10μCi) .\n4.PTH (39-84) antibody Coated Tubes：2 packages of 50 tubes each plus desiccant. The tubes are coated with polyclonal goat anti-PTH (39-84). The desiccant contains silica.\n5.Wash Concentrate：One bottle contains 30 ml of a 30 fold concentrate of phosphate buffered saline with sodium azide 1.5% (w/v) and detergent.\n