宙斯TPO/Tg檢驗試劑組

醫療器材許可證 · 許可證字號：衛署醫器輸字第016445號

許可證字號

衛署醫器輸字第016445號

有效日期

2031/04/20

發證日期

2006/04/20

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHA00601644508

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

效能

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。

醫器主類別一

C 免疫學及微生物學

醫器次類別一

C.5870 甲狀腺自體抗體免疫試驗系統

主成分略述

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 distinguishabl…展開

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收合

醫器規格

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。

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.

製造廠國別

US

異動日期

2026/04/10

製造許可登錄編號

QSD4350

建立時間 2026-09-22 15:59:34 · 更新時間 2026-09-22 15:59:34