宙斯EB病毒檢驗系統（未滅菌）
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名宙斯EB病毒檢驗系統（未滅菌）的英文品名是AtheNA Multi-LyteTM EBV Test System（Non-Sterile）, 許可證字號是衛署醫器輸壹字第003109號, 有效日期是2026/03/23, 許可證種類是09, 效能是檢測檢體中之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。, 主成分略述是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..., 醫器規格是A92001 (96 tests)A92001M (96 tests)A92001G (96 tests), 限制項目是輸 入, 申請商名稱是碩景股份有限公司.
| 許可證字號 | 衛署醫器輸壹字第003109號 |
| 註銷狀態 | (空) |
| 註銷日期 | (空) |
| 註銷理由 | (空) |
| 有效日期 | 2026/03/23 |
| 發證日期 | 2006/03/23 |
| 許可證種類 | 09 |
| 舊證字號 | (空) |
| 醫療器材級數 | 1 |
| 通關簽審文件編號 | DHA04400310904 |
| 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） |
| 效能 | 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 | (空) |
| 包裝 | (空) |
| 醫器主類別一 | C 免疫學及微生物學 |
| 醫器次類別一 | C.3235 EB病毒血清試劑 |
| 醫器主類別二 | (空) |
| 醫器次類別二 | (空) |
| 醫器主類別三 | (空) |
| 醫器次類別三 | (空) |
| 主成分略述 | 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. 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 |
| 醫器規格 | A92001 (96 tests)A92001M (96 tests)A92001G (96 tests) |
| 限制項目 | 輸 入 |
| 申請商名稱 | 碩景股份有限公司 |
| 申請商地址 | 臺北市信義區松德路74號8樓 |
| 申請商統一編號 | 80672330 |
| 製造商名稱 | ZEUS SCIENTIFIC, INC. |
| 製造廠廠址 | 200 EVANS WAY BRANCHBURG, NEW JERSEY 08876, U.S.A. |
| 製造廠公司地址 | (空) |
| 製造廠國別 | US |
| 製程 | (空) |
| 異動日期 | 2020/12/17 |
| 製造許可登錄編號 | (空) |
許可證字號衛署醫器輸壹字第003109號 |
註銷狀態(空) |
註銷日期(空) |
註銷理由(空) |
有效日期2026/03/23 |
發證日期2006/03/23 |
許可證種類09 |
舊證字號(空) |
醫療器材級數1 |
通關簽審文件編號DHA04400310904 |
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） |
效能檢測檢體中之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(空) |
包裝(空) |
醫器主類別一C 免疫學及微生物學 |
醫器次類別一C.3235 EB病毒血清試劑 |
醫器主類別二(空) |
醫器次類別二(空) |
醫器主類別三(空) |
醫器次類別三(空) |
主成分略述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. 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 |
醫器規格A92001 (96 tests)A92001M (96 tests)A92001G (96 tests) |
限制項目輸 入 |
申請商名稱碩景股份有限公司 |
申請商地址臺北市信義區松德路74號8樓 |
申請商統一編號80672330 |
製造商名稱ZEUS SCIENTIFIC, INC. |
製造廠廠址200 EVANS WAY BRANCHBURG, NEW JERSEY 08876, U.S.A. |
製造廠公司地址(空) |
製造廠國別US |
製程(空) |
異動日期2020/12/17 |
製造許可登錄編號(空) |
宙斯EB病毒檢驗系統（未滅菌）地圖 [ 導航 ]
宙斯EB病毒檢驗系統（未滅菌）的地址位於
臺北市信義區松德路74號8樓