適應症
利用酵素免疫定量方法檢測血清或血漿中的CRP。  
劑型
 
包裝
DSL-10-42100: 96 wells 
許可證字號
衛部藥製字第015904號 
註銷狀態
註銷日期
2012-11-26  
註銷理由
838 
有效日期
2011-01-17  
發證日期
2006-01-17  
許可證種類
09 
中文品名
常盈C反應蛋白酵素免疫分析法 
英文品名
DSL C-Reactive Protein ELISA 
藥品類別
C 免疫學及微生物學裝置 
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
DHA00601590409 
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 REAGENTS A. Anti-US CRP Antibody-Coated Microtitration Strips:One stripholder, containing 96 polystyrene microtiter wells with rabbit, anti-US CRP antibody immobilized to the inside wall of each well.B. US CRP Standards:One vial, 42 mL, labeled A, containing 0 ng/mL, US CRP and five vials, 0.5 mL each labeled B-F, containing concentrations of approximately 10, 30, 100, 250 and 500 ng/mL US CRP in a protein-based buffer with a non-mercury preservative.C. US CRP ControlsTwo vials, 50 mL, Levels I and II, containing low and high concentrations of US CRP in a protein-based buffer with non-mercury preservative.D. US CRP Antibody-Enzyme Conjugate ConcentrateOne vial, containing 0.3 mL of a solution of US CRP antibody conjugated to horseradish peroxidase in a buffer with a non-mercury preservative.E. Assay Buffer BTwo bottles, 28 mL each, containing a protein based (BSA)-buffer with a non-mercury preservative. F. TMB Chromogen SolutionOne vial, 11 mL, containing a solution of tetramethylbenzidine (TMB) in citrate