適應症
配合”拜耳”全自動冷光免疫分析系統,檢測血清或紅血球的葉酸。  
劑型
 
包裝
(1) ADVIA Centaur FOL (500 tests, 100 tests)(2) ADVIA Centaur FOL DTT/Releasing Agent (600 tests)(3) ACS:180 FOL (150 tests, 50 tests) 註銷規格:ACS: 180 FOL (150 tests, 50 tests)(原94年12月6日核定之ACS: 180 FOL仿單標籤核定本予以作廢)。以下空白。 
許可證字號
衛部藥製字第015243號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-12-05  
發證日期
2005-12-05  
許可證種類
09 
中文品名
"西門子" 葉酸試劑組 
英文品名
Reagents for Folate (FOL) Assay 
藥品類別
A 臨床化學及臨床毒理學 
申請商地址
臺北市南港區園區街3號2樓之2 
通關簽審文件編號
DHA00601524304 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
SIEMENS HEALTHCARE DIAGNOSTICS INC. 333 CONEY ST. EAST WALPOLE, MA 02032, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 (1) ADVIA Centaur FOL: lite reagent, solid phase, binding protein, low calibrator, high calibrator(2) ADVIA Centaur FOL DTT/Releasing Agent: DTT, releasing agent(3) ACS: 180 aTG: lite reagent, solid phase, binding protein, DTT, releasing agent, low calibrator, high calibratorlite reagent: folate labeled with acridinium ester(~9.8 ng/mL) in buffer bovine serum albumin, sodium azide(0.1%), and preservativessolid phase: purified avidin (~20 ug/mL) covalently coupled to paramagnetic particles in buffer with human serum albumin and preservativesbinding protein: purified folate binding protein (~1.0 ug/mL) covalently coupled to biotin in buffer with bovine serum albumin and preservativesDTT: dithiothreitol (~95 mg/mL) in liquid formReleasing agent: sodium hydroxideCalibrators: after reconstitution, low or high levels of N-5-methyl-tetrahydrofolic acid in buffer with human serum albumin with sodium azide (<0.1%) and preservatives