適應症
此ANAFASTTM 測試系統是利用組織培養作為樣本,由間接免疫螢光抗體法來檢測以及滴定分析循環在人體血清之抗核抗體(ANA)。  
劑型
 
包裝
#1670: 240 tests 
許可證字號
衛部藥製字第015629號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-12-16  
發證日期
2005-12-16  
許可證種類
09 
中文品名
戴思林快速人類自體抗體免疫試驗系統 
英文品名
ANA FastTM: Indirect Fluorescent Antibody kit 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
新北市汐止區福德三路369號12樓 
通關簽審文件編號
DHA00601562900 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIASORIN INC. 1951 NORTHWESTERN AVE. P. O. BOX 285 STILLWATER, MN U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Substrate Slides:Each HEp-2 well slide contains HEp-2 cell grown and fixed on the slide.Fluorescent Antibody Conjugate:Goat or rabbit (see vial label) anti-human immunoglobulin conjugated with fluroescein isothiocyanate (FITC). Evans Blue is added as a counterstain.ANA (Homogeneous) Positive Control Serum:Ready to use human serum in dropper vial containing antinuclear antibodies demonstrating a strong homogeneous staining reaction on HEp-2 cells.ANA (Homogeneous) Endopint Reference Control Serum:Ready to use human serum in dropper vial containing antinuclear antibodies demonstrating a minimal homogeneous staining reaction on HEp-2 cells.Autoantibody Negative Control Serum:Ready to use human serum in dropper vial containing no detectable autoantibodies. Sodium azide 0.1% is added as a presercative.PBS:Contains dry granular phosphate buffered saline blend.Mounting Medium:Ready to use dropper vial. Contains phosphate buffered glycerolBlotting Strips