邦迪斯 HEp-2 抗核抗體套組
The Binding Site HEP-2 ANA KITS

適應症
本試劑組利用免疫螢光染色方法檢測人體中抗核抗體的效價和篩檢。此檢測協助診斷全身性紅斑性狼瘡systemic lupus erythematosus (SLE)，Sjogren's Syndrome，類風濕性關節炎rheumatoid arthritis和其他結締組織疾病。  
劑型
 
包裝
FK001.1 Hep-2 ANA IFA kits, FK001.2 Hep-2 ANA IFA kits, FK001.6 Hep-2 ANA IFA kits, FK001.7 Hep-2 ANA IFA kits, FS001.1 Hep-2 ANA 10 x 5 well Slides, FS001.2 Hep-2 ANA 25 x 10 well Slides, FS001.3 Hep-2 ANA 100 x 10 well Slides, FS001.6 Hep-2 ANA 20 x 12 well Slides, FS001.7 Hep-2 ANA 100 x 12 well Slides 
許可證字號
衛部藥製字第018972號 
註銷狀態
1 
註銷日期
2015-04-24  
註銷理由
838 
有效日期
2013-03-17  
發證日期
2008-03-17  
許可證種類
09 
中文品名
邦迪斯 HEp-2 抗核抗體套組 
英文品名
The Binding Site HEP-2 ANA KITS 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
太暘生物科技股份有限公司  
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
DHA00601897202 
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 Hep-2 substrate on 5-, 10-, 12- or 24-well slides\nKits only: 1. Positive control serum (homogeneous pattern, 3+ staining intensity) containing 0.099% sodium azide. Prediluted, ready for use. 2. Positive control serum (centromere pattern, 3+ staining intensity) containing 0.099% sodium azide. Prediluted, ready for use. 3. Negative control serum (universally negative for all autoantibodies) containing 0.099% sodium azide. Prediluted, ready for use. 4. Affinity purified sheep anti-human IgG (H+L) fluorescein containing 0.099% sodium azide. Prediluted, ready for use. 5. 1% Evans Blue, as an optional counterstain. 6. Phosphate buffered saline (PBS) provided as a 20-fold concentrate in liquid form. 7. Blotters, to blot around wells after washing. 8. Mounting medium containing an anti-fading agent (DABCO, 1, 4 diazabicyclo [2.2.2] octane). 9. Coverslips.