適應症
定量測定血清裡人絨毛膜的促性腺激素(hCG)濃度。  
劑型
 
包裝
#10-8300 Intact hCG: 96 wells/set 
許可證字號
衛部藥製字第016601號 
註銷狀態
註銷日期
2013-01-18  
註銷理由
838 
有效日期
2011-05-19  
發證日期
2006-05-19  
許可證種類
09 
中文品名
迪斯爾完整絨毛膜促性腺激素酵素免疫分析套組 
英文品名
DSL INTACT hCG ELISA 
藥品類別
A 臨床化學及臨床毒理學 
申請商地址
新北市汐止區康寧街169巷25號13樓 
通關簽審文件編號
DHA00601660109 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BOULEVARD WEBSTER, TEXAS 77598 U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Anti-hCG-Coated Microtitration Strips:coated with anti-hCG antibody.\nI-hCG Standard A/Sample Diluent:containing 0 mIU/mL I-hCG in equine serum with sodium azide as a preservative.\nI-hCG Standards B-G:containing concentrations of approximately 3, 10, 30, 100, 300 and 1000 mIU/mL I-hCG in equine serum with sodium azide as a peservative.\nI-hCG Controls:containing low and high concentrations of I-hCG in equine serum with sodium azide as a preservative.\nAssay Buffer:(Green):containing a protein-based (BSA) buffer with a non-mercury preservative.\nI-hCG Antibody-Enzyme Conjugate Concentrate:containing anti-hCG antibody conjugated to the enzyme horseradish peroxidase in a protein-based(BSA) buffer with a non-mercury preservative.\nTMB Chromogen Solution:containing a solution of tetramethylbenzidine (TMB) in citrate buffer with hydrogen peroxide.\nWash Concentrate:containing buffered saline with a nonionic detergent.\nStopping Solution:containing 0.2 M Sulfuric acid.