適應症
AESKULISA ANA-HEp2為一個固態的酵素免疫分析法,用來檢測人類血清中抗HEp2細胞抗原之免疫球蛋白G抗體定性分析。  
劑型
 
包裝
# 3115 96 tests 
許可證字號
衛部藥製字第019609號 
註銷狀態
註銷日期
2015-04-24  
註銷理由
838 
有效日期
2013-12-10  
發證日期
2008-12-10  
許可證種類
09 
中文品名
阿斯古抗HEp2細胞抗原免疫酵素分析檢測試劑 
英文品名
AESKULISA ANA-HEp2 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
新北市汐止區康寧街169巷25號13樓 
通關簽審文件編號
DHA00601960901 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
AESKU DIAGNISTICS. MIKROFORUM RING 2, 55234 WENDELSHEIM, GERMANY DE
成份表
處方標示 成分名稱 含量 單位
1 阿斯古抗HEp2細胞抗原免疫酵素分析檢測試劑\n5x Sample Buffer 1 vial, 20 ml - 5x concentrated (capped white: yellow solution)\nContaining: Tris, NaCl, BSA, sodium azide < 0.1% (preservative)\n50x Wash Buffer 1 vial, 20 ml - 50x concentrated (capped white: green solution)\nContaining: Tris, NaCl, BSA, sodium azide < 0.1% (preservative)
1 Ready to use:\nNegative Control 1 vial, 1.5 ml (capped green: yellow solution)\nContaining: Human serum (diluted), sodium azide < 0.1% (preservative)\nPositive Control 1 vial, 1.5 ml (capped red: yellow solution)\nContaining: Human serum (diluted), sodium azide < 0.1% (preservative)\nCut-off Calibrator 1 vial, 1.5 ml (capped blue: yellow solution)\nContaining: Human serum (diluted), sodium azide < 0.1% (preservative)\nConjugate 1 vial, 15 ml IgG (capped blue: blue solution)\nContaining: Anti-human immunoglobulins conjugated to horseradish peroxidase\nTMB Substrate 1 vial, 15ml (capped black)\nContaining: Stabilized TNB/H2O2\nStop Solution 1 vial, 15ml (capped white: colorless solution)\nContaining: 1M Hydrochloric Acid\nMicrotiterplate 12x8 well strips with breakaway microwells