亞培設計師葉酸檢驗試劑組
ABBOTT ARCHITECT Folate

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)。  
劑型
 
包裝
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)。 
許可證字號
衛部藥製字第017543號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2026-09-28  
發證日期
2006-09-28  
許可證種類
09 
中文品名
亞培設計師葉酸檢驗試劑組 
英文品名
ABBOTT ARCHITECT Folate 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
美商亞培股份有限公司台灣分公司  
申請商地址
臺北市中山區民生東路3段49號5樓、6樓及51號6樓 
通關簽審文件編號
DHA00601754300 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ABBOTT IRELAND DIAGNOSTICS DIVISION LISNAMUCK, LONGFORD, CO. LONGFORD, IRELAND IE
成份表
處方標示 成分名稱 含量 單位
1 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.