宙斯EB病毒檢驗系統（未滅菌）
AtheNA Multi-LyteTM EBV Test System（Non-Sterile）

適應症
檢測檢體中之EB病毒之抗原(EBV-VCA gp-125, total EBV-EA, and recombinant EBNA-1)、EB病毒之外鞘抗原(viral capsid antigen, VCA)對應的IgG、IgM。  
劑型
 
包裝
A92001 (96 tests)A92001M (96 tests)A92001G (96 tests) 
許可證字號
44003109 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2026-03-23  
發證日期
2006-03-23  
許可證種類
09 
中文品名
宙斯EB病毒檢驗系統（未滅菌） 
英文品名
AtheNA Multi-LyteTM EBV Test System（Non-Sterile） 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
碩景股份有限公司  
申請商地址
台北市信義區松德路７４號８樓 
通關簽審文件編號
DHA04400310904 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NEW JERSEY 08876, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Reactive Reagents:\n1. All reactive reagents contain sodium azide as a preservative at a concentration of 0.1% (w/v)\n2. multiplexed bead suspension 5.5ml bottle. The suspension distinguishable 5.6 micron polystyrene beads that are conjugated with EBV VCA gp125 antigen (affinity purified from EBV infected cell lines). The bead mix also contains one beads set designed to detect non-specific and/or RF IgM antibodies in the patient sample and four separate bead sets usded for assay calibration.\n3. multiplexed bead suspension. 5.5 ml bottle. The suspension distinguishable 5.6 micron polystyrene beads that are conjugated the following antigens: affinity purified EBV VCA gp125, affinity purified EA (roughly equal parts EA-D and EA-R) and recombinant EBNA-1. The bead mix also contains one bead set designed to detect non-specific antibodies in the patient sample and four separate bead sets used for assay calibration.\n4. Phycoerythrin conjugated goat anti-human IgM (μ chain specific).15 ml amber bottle.
1 5. Phycoerythrin conjugated goat anti-human IgM (Fc chain specific).15 ml amber bottle.\n6. Human positive serum control. One, 0.2 ml vial.\n7. Human negative serum control. One, 0.2 ml vial.\n8. Sample diluent. One 50 ml bottle containing phosphate-buffered-saline. NOTE, the sample diluent will change color in the presence of serum.\nNON reactive Components:\n1. One, 96-well polystyrene assay plate\n2. One, 96-well diluent plate\n3. One, 96-well filtration plate for rinsing microspheres\n4. Data Labels: One label adhered to the inside lid of the kit box and a second label is inside the kit box.\n5. Package insert providing instructions for use\n6.Calibration CD: A compact disc that includes all lot-specific kit calibration values required for specimen analysis and assay quality control.\n