"西門子" Ｎ胱蛋白C乳膠試劑

醫療器材許可證 · 許可證字號：衛署醫器輸字第016465號

許可證字號

衛署醫器輸字第016465號

有效日期

2031/04/25

發證日期

2006/04/25

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHA00601646501

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

效能

定量測定人類血清和肝素化血漿中胱蛋白C。

醫器主類別一

A 臨床化學及臨床毒理學

醫器次類別一

A.1225 肌氨酸酐試驗系統(Creatininetestsystem)

主成分略述

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 (1…展開

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收合

醫器規格

OQNM;OQUB (5 ml x 6)，以下空白。 醫療器材標籤、說明書或包裝變更為：詳如醫療器材標籤、說明書或包裝核定本(原97年8月5日醫療器材仿單標籤核定本回收作廢)。以下空白

限制項目

輸 入

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

申請商統一編號

24843993

製造商名稱

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

製造廠廠址

EMIL-VON-BEHRING-STR. 76, D-35041 MARBURG, GERMANY

製造廠國別

DE

異動日期

2026/04/16

製造許可登錄編號

QSD5584

建立時間 2026-09-22 15:59:33 · 更新時間 2026-09-22 15:59:33