“代首林”25-羥基維生素 D 放射免疫分析試劑
“DiaSorin”25-Hydroxyvitamin D 125I RIA

適應症
用來定量檢測人體中血清或血漿中的25-羥基維生素 D 與其他氫氧化維生素 D 代謝物，以評估維生素 D 缺乏症。  
劑型
 
包裝
68100E (100tests) 
許可證字號
衛部藥製字第018402號 
註銷狀態
1 
註銷日期
2014-04-15  
註銷理由
838 
有效日期
2012-07-31  
發證日期
2007-07-31  
許可證種類
09 
中文品名
“代首林”25-羥基維生素 D 放射免疫分析試劑 
英文品名
“DiaSorin”25-Hydroxyvitamin D 125I RIA 
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
DHAS0601840208 
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 AVENUE, STILLWATER, MN 55082-0285, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 1.25-OH-D NSB/Addition Buffer：Phosphate-gelatin buffer containing 0.1% sodium azide. This component has a dual function. It will serve both as the NSB buffer and as the Addition buffer.\n2. 25-OH-D3 Calibrator：Six (25-OH-D3) calibrators at concentrations ranging from 0-100 ng/mL are prediluted in processed human serum containing 0.1% sodium azide.\n3. 25-OH-D Antiserum：Goat anti 25-OH-D serum is diluted in phosphate-gelatin buffer containing 0.1% sodium azide.\n4. 25-OH-D3 Tracer：An iodinated [125I] analog of 25-OH-D3 is diluted in an ethanol-phosphate buffer.\n
1 5.Donkey Anti-Goat (DAG) Precipitating Complex：Donkey anti-goat serum, normal goat serum, and polyethylene glycol are diluted in a BSA-borate buffer containing gentamycin sulfate and 0.1% sodium azide.\n6. 25-OH-D Controls：Human serum containing 0.1% sodium azide is spiked with the appropriate amounts of 25-OH-D3 to obtain control concentrations within specified ranges. Mix thoroughly and treat as an unknown samples. Control 1 represents a low-normal range and Control 2 represents a high normal range.\n7.Acetonitrile：Qualified for use with this kit. This product contains dry natural rubber.\n