適應症
被動血球凝集法檢測人血清、血漿和腹水中之AFP(α-fetoprotein)。  
劑型
 
包裝
36 Tests/Kit,100Tests/Kit 
許可證字號
衛部藥製字第015546號 
註銷狀態
註銷日期
2013-01-14  
註銷理由
838 
有效日期
2010-12-13  
發證日期
2005-12-13  
許可證種類
09 
中文品名
速樂定胎兒蛋白檢驗試劑 
英文品名
SERODIA-AFPmono 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
台富製藥股份有限公司  
申請商地址
桃園市大園區溪海村崙頂36號 
通關簽審文件編號
DHA00601554609 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
FUJIREBIO INC., HACHIOJI FACILITY 51, KOMIYA-CHO, HACHIOJI-SHI TOKYO, 192-0031 JAPAN JP
成份表
處方標示 成分名稱 含量 單位
1 B:Serum Diluent(Liquid)\nPhosphate buffer saline containing normal rabbit sera and 0.1% sodium azide.\nC:Antibody-Sensitized Cells(Lyophilized)\nLyophilized preparation of fixed chicken erythrocytes sensitized with anti-AFP mouse antibody. The reconstituted reagent includes 0.66% anti-AFP Antibody-Sensitized Cells.\nD:Control Cells(Lyophilized)\nLyophilized preparation of fixed chicken erythrocytes sensitized with mouse IgG.\nE:Positive Control(Liquid)\n1:10 diluted preparation of human serum positive for AFP with Serum Diluent. The control include gives a 1:320 end point titer at final dilution when tested according to the Positive Control Test Procedure\nF:Absorbent Cells (Lyophilized)\nLyophilized preparation of chicken erythrocytes sensitized with mouse IgG..\n