亞培設計師弓漿蟲免疫球蛋白M抗體檢驗試劑組

醫材分類

• C.3780弓漿蟲血清試劑

醫器規格

6C 20-256C 20-356C 20-016C 20-10 型號6C20-01中文品名變更為：亞培設計師弓漿蟲免疫球蛋白M抗體檢驗試劑組 校正液。 型號6C20-10中文品名變更為：亞培設計師弓漿蟲免疫球蛋白M抗體檢驗試劑組 品管液。 規格、標籤、說明書或包裝變更為：詳如核定之中文說明書。（原98年10月27日核定之標籤、說明書或包裝予以回收作廢）

限制項目

輸 入

適應症

效能變更為：本產品以化學冷光微粒免疫分析法（CMIA）定性偵測人類血清及血漿中的弓漿蟲（Toxoplasma gondii）IgM抗體。

醫材資訊

主成分

ARCHITECT Toxo IgM Reagent kit (100/500 Tests)\nMicroparticles：1 Bottle (6.6 mL per 100-test bottle/27.0 mL per 500-test bottle) anti-human IgM (mouse, monoclonal) antibody coated microparticles in TRIS buffer with protein stabilizers and detergent. Minimum concentration: 0.08% solids. Preservatives: antimicrobial agents.\nConjugate：1 Bottle (5.9 mL per 100-test bottle/26.3 mL per 500-test bottle) conjugate complex consisting of acridinium-labeled anti-Toxoplasma p30 antigen (mouse, monoclonal) antibody and native Toxoplasma gondii lysate in phosphate buffer with protein stabilizers and detergent. Minimum concentration: 25 μg/mL. Preservative: sodium azide. Control Color Target Anti-Toxo IgM Control Range \n Concentration (Index) (Index)\nCONTROL- Natural N/A < 0.40\nCONTROL+ Natural 1.50 0.75 – 2.25\nControl Color Target Anti-Toxo IgM Control Range \n Concentration (S/CO) (S/CO)\nCONTROL- Natural N/A < 0.67\nCONTROL+ Natural 2.50 1.25 – 3.75 ARCHITECT Toxo IgM Calibrator\n1 Bottles (4.0 mL) of ARCHITECT Toxo IgM Calibrator contains anti-Toxoplasma p30 antigen (human, monoclonal) IgM antibody prepared in recalcified human plasma.\n\nARCHITECT Toxo IgM Controls\n2 Bottles (4.0 mL each) of ARCHITECT Toxo IgM Controls: Negative Control and Positive Control. The controls are at the following concentrations:

製造商

ABBOTT GMBH

製造國

DE

申請商

美商亞培股份有限公司台灣分公司

有效日期

2029/08/31

發證日期

2009/08/31

供應藥局

目前尚無登錄供應此品項的藥局資料。