適應症
猴子食道切片用來篩檢人類血清中的表皮抗原(intra-epidermal antigens)或基底細胞膜(basement membrane zones)抗體與肌內膜抗體(endomysial antibodies)  
劑型
 
包裝
FK208.1, FK208.2, FS208.1, FS208.2, FS208.A, FS208.B 
許可證字號
衛部藥製字第020395號 
註銷狀態
註銷日期
2018-05-28  
註銷理由
838 
有效日期
2014-10-21  
發證日期
2009-10-21  
許可證種類
09 
中文品名
邦迪斯猴子食道免疫螢光染色套組/玻片 
英文品名
THE BINDING SITE MONKEY OESOPHAGUS IFA KITS/SLIDES 
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
DHA00602039508 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
THE BINDING SITE LIMITED. WARSTOCK ROAD, KINGS HEATH, BIRMINGHAM, B14 4RT, UNITED KINGDOM GB
成份表
處方標示 成分名稱 含量 單位
1 1. Monkey oesophagus sections on 5- or 10-well slides.\nKits only:\n2. Two positive control sera (derived from human serum), one giving “chicken wire pemphigus pattern and the other “reticulin like”endomysial pattern on monk oesophagus sections, containing 0.099% sodium azide. Prediluted, ready for use.\n3. Negative control serum, universally negative for all autoantibodies, containing 0.099% sodium azide. Prediluted, ready for use.\n4. Phosphate buffered saline (PBS), provided as a 20-fold concentrate in liquid form.\n5. Affinity purified sheep anti-human IgG (H&L), (monkey adsorbed) fluorescein conjugate and anti-human IgA fluorescein conjugate, containing 0.099% sodium azide. Prediluted, ready for use.\n6. 1% Evans Blue, as an optional counterstain.\n7. Blotters.\n8. Mounting medium, containing an anti-fading agent (DABCO, 1,4 diazabicyclo [2.2.2] octane).\n9. Coverslips.