"西門子" Ｎ胱蛋白C乳膠試劑
"Siemens" N Latex Cystatin C

適應症
定量測定人類血清和肝素化血漿中胱蛋白C。  
劑型
 
包裝
OQNM;OQUB (5 ml x 6) 
許可證字號
衛部藥製字第016465號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2026-04-25  
發證日期
2006-04-25  
許可證種類
09 
中文品名
"西門子" Ｎ胱蛋白C乳膠試劑 
英文品名
"Siemens" N Latex Cystatin C 
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
DHA00601646501 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH EMIL-VON-BEHRING-STR. 76, D-35041 MARBURG, GERMANY DE
成份表
處方標示 成分名稱 含量 單位
1 OQNM:\nN Cystatin C Reagent consists of a suspension of polystyrene particles coated with approximately 0.03 g/l anti-human cystatin C from rabbits.\nN Cystatin C Supplementary Reagent A contains rabbit immunoglobulin (14 g/l) in buffered solution.\nN Cystatin C Supplementary Reagent B consists of an aqueous solution of polyethylene glycol sorbitan monolaureate (85 g/l) and polyethylene glycol ether (27 g/l)\nN Cystatin C Control, Level 1 and N Cystatin C Control, Level 2 are lyophilized polygeline with urine proteins of human origin. The concentration of cystatin C was standaedized with reference to purified cystatin C. Once reconstituted, the controls contain the cystatin C concentrations as indicated on the respective vial label.\nOQUB: Cleaner SCS contains sodium hydroxide (< 2.0%) and a detergent.\n