伊姆諾康塞斯特螢光自體抗核抗體測定組
Immuno Concepts Fluorescent HEp-2 & HEp-2000 ANA Test Kit

適應症
利用間接螢光抗體測定法半定量測定人類血清中的自體抗核抗體。  
劑型
 
包裝
#2200-RO，#2200-14-RO，#2200，以下空白。 
許可證字號
衛部藥製字第016152號 
註銷狀態
1 
註銷日期
2018-05-10  
註銷理由
838 
有效日期
2016-03-15  
發證日期
2006-03-15  
許可證種類
09 
中文品名
伊姆諾康塞斯特螢光自體抗核抗體測定組 
英文品名
Immuno Concepts Fluorescent HEp-2 & HEp-2000 ANA Test Kit 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
泓展有限公司  
申請商地址
台北市中山區敬業一路１６０號７樓 
通關簽審文件編號
DHA00601615206 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
IMMUNO CONCEPTS NA LTD 9825 Goethe Road #350, Sacramento, California 95827, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Substrate Slides: Catalog No. 2007 (seven-well); 2013\n(thirteen-well): HEp-2 cells (with mitotic figures) grown and stabilized directly on the test wells. \n\nCatalog No. 2007-Ro (seven-well);\n2013-Ro (thirteen-well): HEp-2000R cells (with mitotic\nfigures) grown and stabilized directly on the test wells.\nThese are HEp-2 cells that have been stably transfected\nwith the SSA/Ro autoantigen. \n\nSSA/Ro Positive Control(Hep-2000 ANA Test Kit only)\n: Catalog No. 2035-Ro. Ready-to-use dropper vial containing \n1.0 ml positive human control serum with antibody specific to SSA/Ro antigens.\n\n
1 Homogeneous Positive Control: Catalog No. 2021. Ready-to-use dropper vial containing 1.0 ml positive human control serum with antibody specific to DNA and/or DNP nuclear antigens. \n\nSpeckled Positive Control: Catalog No. 2022. Ready- to-use dropper vial containing 0.5 ml positive human control serum with antibody specific to Sm and/or RNP nuclear antigens. \n\nNucleolar Positive Control: Catalog No. 2023. Ready- to-use dropper vial containing 0.5 ml positive human control serum with antibody specific to nucleolar antigens. \n\nCentromere Positive Control: Catalog No. 2025. Ready- to-use dropper vial containing 0.5 ml positive human control serum with antibody specific to chromosomal centromeres (kinetochore). \n\nTitratable Control Serum: Catalog No. 2026. Ready-to- use vial containing 1.0 ml positive human control serum to be treated as an undiluted patient sample. \n\nNegative Control Serum: Catalog No. 2031. Ready-\nto-use dropper vial containing 1.0 ml negative human control serum.\n\nFlu
1 Counterstain (Hep-2 ANA Test Kit only): Catalog No. 1105. Ready-to-use dropper vial containing 5.0 ml Evans blue solution (0.5% in PBS).\n\nNON-REACTIVE REAGENTS\n\nPBS Buffer Powder: Catalog No. 1011. Phosphate-buff- ered saline powder (0.01 M, pH 7.4 ± 0.2). \n\n\nSemi-Permanent Mounting Medium: Catalog No. 1111. Ready-to-use dropper vial containing 5.0 ml glycerol- based mounting medium, pH 9.1 ± 0.2. \n\nCoverslips: Catalog No. 1041. Each packet contains ten 24x60 mm No. 1 glass coverslips.\n\n