適應症
提供人血清或血漿中二聚抑制素A的定量檢測。  
劑型
 
包裝
DSL-10-28100-1: 1 x 96 wellsDSL-10-28100-4: 4 x 96 wells 
許可證字號
衛部藥製字第015962號 
註銷狀態
註銷日期
2012-11-26  
註銷理由
838 
有效日期
2011-02-03  
發證日期
2006-02-03  
許可證種類
09 
中文品名
常盈抑制素A酵素免疫試劑組 
英文品名
DSL Inhibin A ELISA 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
常盈實業股份有限公司  
申請商地址
台北市北投區永興路一段49號 
通關簽審文件編號
DHA00601596200 
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-Inhibin A-Coated Microtitration Strips:\nOne stripholders, each containing 96 polystyrene microtiter wells coated with anti-Inhibin βA subunit antibody immobilized to the inside wall of each well. *DSL-10-28100 (4-plate) contains four (4) stripholders.\nInhibin A Standard A/Sample Diluent:\nOne vial, 2 mL each, labeled A, containing 0 pg/mL dimeric Inhibin A in fetal bovine serum with a nonmercury preservative. \n*DSL-10-28100 (4-plate) contains two (2) vials.\nInhibin A Standards:\nOne set of Standards, 1 mL each, labeled B-G, containing concentrations of approximately 10, 30, 100, 250, 500, and 1000 pg/mL dimeric Inhibin A in fetal bovine serum with a non-mercury preservative. \n*DSL-10-28100 (4-plate) contains two (2) sets of
1 Standards.\nInhibin A Controls:\nOne set of Controls, 1.0 mL each, Levels I and II, containing low and high concentrations of Dimeric Inhibin A in fetal bovine serum with a non-mercury preservative. \n*DSL-10-28100 (4-plate) contains two (2) sets of Controls.\n\nE. Inhibin A Sample Buffer A:\nOne bottle, 10 mL, containing a protein-based buffer with a non-mercury preservative. Store at 2-8°C until\nexpiration date.\n*DSL-10-28100-4 contains one (1)-30 mL bottle.\nF. Inhibin A Sample Buffer B:\nOne bottle, 10 mL, containing a protein-based buffer with a non-mercury preservative. Store at 2-8°C until\nexpiration date.\n*DSL-10-28100 (4-plate) contains one (1)-30 mL bottle.\nG. Inhibin A Antibody-Enzyme Conjugate Concentrate:\nOne vial, containing 0.6 mL of a solution of anti-Inhibin α-subunit antibody conjugated to horseradish\nperoxidase in a protein-based buffer with a non-mercury preservative. Dilute prior to use in Conjugate\nDiluent. Store at 2-8°C until expiration date.\n*DSL-10-28100 (4-plate) contains f