亞培設計師葉酸檢驗試劑組

醫材分類

• A.1295葉酸試驗系統

醫器規格

變更規格:1P-01/10/25/35/40/50/3P21-60 規格變更(更正)為:1P74-01/10/25/35/40/50/3P21-60。 規格(期望值)及標籤仿單變更為：詳如中文仿單核定本。（原99年3月18日標籤仿單核定本正本收回作廢） 規格及標籤、說明書或包裝：詳如核定之中文說明書(原106年5月3日核定之標籤、說明書或包裝正本收回作廢)。

限制項目

輸 入

適應症

本產品用於在ARCHITECT i系統上，以化學冷光微粒葉酸結合蛋白質分析法定量檢測人類血清、血漿及紅血球中的葉酸(folate)。

醫材資訊

主成分

Reagent kit: Microparticles: 1 or 4 bottles anti-Folate binding protein coupled to microparticles affinity bound with Folate binding protein, in TRIS buffer with protein stabilizers, antimicrobial agents. Conjugate: 1 or 4 bottles Pteroic acid (PTA)-acridinium labeled conjugate in MES buffer with protein stabilizer, antimicrobial agents. Assay specific diluent: 1 or 4 bottles containing borate buffer, antimicrobial agents. Pre-treatment reagent 1: 1 or 4 bottles containing potassium hydroxide. Pre-treatment reagent 2: 1 or 4 bottles containing dithiotheritol (DTT) in acetic acid buffer with EDTA. Specimen diluent: 1 or 4 bottles Folate specimen diluent containing TRIS buffer with protein stabilizer, sodium azide. Calibrators: 6 bottles of ARCHITECT Folate Calibrators. Calibrator A contains TRIS buffer. Calibrator B through F contain pteroylglutamic acid (PGA) in TRIS buffer. All calibrators contain protein stabilizer, sodium azide. 5mTHF Low Controls: 8 bottles of ARCHITECT Folate 5mTHF Low Control. The control contains 5-methyltetrahydrofolic acid (5mTHF) in TRIS buffer with protein and anti-oxidant stabilizers, sodium azide. Controls: 3 bottles of ARCHITECT Folate Low, Medium and High Controls. Controls contain pteroylglutamic acid (PGA) in TRIS buffer with protein stabilizer, sodium azide. Manual Diluent: 1 bottle containing TRIS buffer with protein stabilizer, sodium azide. RBC Lysis Diluent: 1 bottle containing citric acid and guanidine hydrochloride, antimicrobial agent.

製造商

ABBOTT IRELAND DIAGNOSTICS DIVISION

製造國

IE

申請商

美商亞培股份有限公司台灣分公司

有效日期

2031/09/28

發證日期

2006/09/28

供應藥局

目前尚無登錄供應此品項的藥局資料。