"西門子" 葉酸試劑組
Reagents for Folate (FOL) Assay

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
0 
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 
申請商名稱
西門子醫療設備股份有限公司  
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