因諾瓦類風濕性因子免疫球蛋白G酵素連結免疫分析法檢驗系統
QUANTA Lite RF IgG

適應症
利用免疫酵素法(Enzyme Linked Immunoassay,)進行人類血清檢體內之免疫球蛋白G類風濕性因子(rheumatoid factor,RF)抗體之半定量檢測。  
劑型
 
包裝
#708685(96 tests) 
許可證字號
衛部藥製字第015654號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2025-12-19  
發證日期
2005-12-19  
許可證種類
09 
中文品名
因諾瓦類風濕性因子免疫球蛋白G酵素連結免疫分析法檢驗系統 
英文品名
QUANTA Lite RF IgG 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
碩景股份有限公司  
申請商地址
台北市信義區松德路７４號８樓 
通關簽審文件編號
DHA00601565402 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
INOVA DIANOSTICS, INC. 9900 OLD GROVE ROAD, SAN DIEGO, CA 92131 U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Polystyrene microwell ELISA plate coated with a purified rabbit IgG antigen, (12-1 x 8 wells)\nELISA Negative Control, 1 vial of buffer containing human serum with no human antibodies to RF IgG, prediluted, 1.2mL \nRF IgG ELISA Calibrator A, 1 vial of buffer containing human serum antibodies to RF IgG, prediluted, 1.2mL \nRF IgG ELISA Calibrator B, 1 vial of buffer containing human serum antibodies to RF IgG, prediluted, 1.2mL \nRF IgG ELISA Calibrator C, 1 vial of buffer containing human serum antibodies to RF IgG, prediluted, 1.2mL \n RF IgG ELISA Calibrator D, 1 vial of buffer containing human serum antibodies to RF IgG, prediluted, 1.2mL \n RF IgG ELISA Calibrator E, 1 vial of buffer containing human serum antibodies to RF IgG, prediluted, 1.2mL \n RF IgG ELISA Control, 1 vial of buffer containing human serum antibodies to RF IgG, prediluted, 1.2mL \n HRP Sample Diluent, 1 vial – colored pink containing Tris-buffered saline, Tween 20 \n
1 HRP Wash Concentrate, 1 vial of 40x concentrate containing Tris-buffered saline and Tween 20, 25mL \nRF HRP IgG Conjugate, (rabbit), anti-human IgG, 1 vial – colored yellow containing buffer \nTMB Chromogen, 1 vial containing stabilizers, 10mL \nHRP Stop Solution, 0.344M Sulfuric Acid, 1 vial – colorless, 10mL\n