適應症
利用放射免疫分析法定量分析人類血清或血漿中的骨鈣蛋白。  
劑型
 
包裝
#15065I: 65 tubes/kit#15130I: 130 tubes/kit 
許可證字號
衛部藥製字第016494號 
註銷狀態
註銷日期
2012-10-26  
註銷理由
838 
有效日期
2011-05-01  
發證日期
2006-05-01  
許可證種類
09 
中文品名
岱安韶韻 骨鈣蛋白125I RIA套組 
英文品名
DiaSorin Osteocalcin 125I RIA Kit 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
新科化實業有限公司  
申請商地址
臺北市中正區忠孝西路1段50號14樓之4 
通關簽審文件編號
DHAS0601649403 
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 4.1 Osteocalcin Calibrator 0: BSA-borate buffer contains 0.2% sodium azide as a preservative.\n4.2 Osteocalcin Calibrator: Bovine osteocalcin calibrator, at a normal concentration of 25 ng/ml, is diluted in BSA-borate buffer containing 0.1% sodium azide. The exact concentration value of the calibrator is assigned according to each lot. This calibrator is of bovine bone origin and has been highly purified by HPLC.\n4.3 Osteocalcin Antiserum: Rabbit anti-osteocalcin serum is diluted in BSA-borate buffer containing 0.5% sodium azide.\n4.4 125I Osteocalcin: Bovine osteocalcin is labeled with iodine-125 and diluted in BSA-borate buffer containing 0.5% sodium azide.\n4.5 Precipitating Complex (GAR-PPT): Normal rabbit serum, pre-precipitated with goat anti-rabbit serum and polyethylene glycol (PEG), is diluted in BSA-borate buffer with 0.1% sodium azide and other preservatives added.\n4.6 Osteocalcin Control: BSA-borate buffer is spiked with the appropriate amount of osteocalcin to obtain a concentration within a sp