宙斯抗核抗體免疫檢驗系統 II

醫材分類

• C.5100抗核抗體免疫試驗系統

醫器規格

A21001：96 tests。以下空白。規格變更：A21001：96 tests變更為A21101：96 tests（原96.11.21核定之中文仿單核定本予以註銷）。以下空白。

限制項目

輸 入

適應症

針對人類血清中8種不同的分析物(包括SSA、SSB、Sm、RNP、Scl-70、Jo-1、中心粒B以及組織蛋白)，對免疫球蛋白G層級的抗體做半定量的偵測，人類血液中的dsDNA的IgG層級的抗體定量檢測，以及ANA的IgG層級的抗體定量檢測 診斷。

醫材資訊

主成分

1.Mutiplexed bead suspension. Ready to use, 5.5 mL bottle. The suspension contains separate distinguishable 5.6 micro polystyrene beads that are conjugated with the following autoantigens: SSA, SSB, Sm, U snRNP B/B’, U1 snRNP 68, U1 snRNP A, U1 snRNP C, Scl-70, Jo-1, Centronmere B, dsDNA, Histone H, and Histone HLY. An additional bead set is included that contains an antigen preparation derived from Hep-2 cells. This bead set contributes to screening ability of the AtheNA Multi-Lyte ANA Assay. Finally, 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.\n2.Phycoerythrin conjugated goat anti-human IgG (γchain specific). Ready to use, 15 mL amber bottle. 3.Human positive serum controls, Three, 0.2 mL vials\n4.Human negative serum controls. One, 0.2 mL vial.\n5.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.

製造商

ZEUS SCIENTIFIC, INC.

製造國

US

申請商

碩景股份有限公司

有效日期

2027/11/15

發證日期

2007/11/15

供應藥局

目前尚無登錄供應此品項的藥局資料。