宙斯TPO/Tg檢驗試劑組
AtheNA Multi-Lyte TPO/Tg Plus Test Kit

適應症
針對人類血清中2種不同的甲狀腺抗原(甲狀腺過氧化酶(TPO)和甲狀腺球蛋白(Tg))所對應之免疫球蛋白G層級的抗體做定量的偵測。  
劑型
 
包裝
A51001: 96 tests。以下空白。規格變更：A51001: 96 tests變更為A51101: 96 tests（原95.5.1核定之中文仿單核定本予以註銷）。以下空白。 
許可證字號
衛部藥製字第016445號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2026-04-20  
發證日期
2006-04-20  
許可證種類
09 
中文品名
宙斯TPO/Tg檢驗試劑組 
英文品名
AtheNA Multi-Lyte TPO/Tg Plus Test Kit 
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
DHA00601644508 
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: (All reactive reagents contain sodium azide as a preservative at a concentration of 0.1% w/v)1. Multiplexed bead suspension. Ready to use, 5.8 mL bottle. The suspension contains separate distinguishable 5.6 micron polystyrene beads that are conjugated with the following antigens: Thyroid Peroxidase (TPO) and Thyroglobulin (Tg). The bead mix also contains one bead set designed to detect non-specific antibodies in the patient sample (if present) and four separate bead sets used for assay calibration.2. Phycoerythin conjugated goat anti-human IgG (γ chain specific). Ready to use, 15 mL amber bottle.3. Human positive serum control. One, 0.2 mL vial.4. Human negative serum control. One, 0.2 mL vial.5. Sample diluent. One 50 mL bottle containing phosphate-buffered-saline. Ready to use.NOTE, the sample diluent will change color in the presence of serum.Non-reactive Components:1. One, 96-well polystyrene assay plate.2. One, 96-well dilution plate.3. One, 96-well filtration plate for rinsing the mic