馬丁彼得皮質醇診斷套組

醫療器材許可證 · 許可證字號：衛署醫器輸字第016248號

許可證字號

衛署醫器輸字第016248號

註銷狀態

已註銷

註銷日期

2023/08/15

註銷理由

許可證已逾有效期

有效日期

2021/03/29

發證日期

2006/03/29

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHAS0601624801

中文品名

馬丁彼得皮質醇診斷套組

英文品名

MP Cortisol CT

效能

用於檢測未經萃取的血清中的皮質醇濃度。

醫器主類別一

A 臨床化學及臨床毒理學

醫器次類別一

A.1205 皮質醇(氫基腎上腺素，及羥皮質固醇)試驗系統

主成分略述

ANTI-CORTISOL COATED TUBES：4 x 25 tubes\nCortisol-3-O-Carboxymethyloxime-BSA was used as the antigen to generate the antiserum in rabbits. This antiserum is covalently bound to the inner surface of a polypropylene tube a…展開

ANTI-CORTISOL COATED TUBES：4 x 25 tubes\nCortisol-3-O-Carboxymethyloxime-BSA was used as the antigen to generate the antiserum in rabbits. This antiserum is covalently bound to the inner surface of a polypropylene tube and is titered to provide 40 to 60% total binding in the absence of non radioactive Cortisol.\nCORTISOL STANDARDS (6)：0.5 mL each\nSix standards are provided at the following concentrations：0, 1.0, 3.0, 10, 30, and 100 ng/dL. These standards have been prepared in a human serum matrix and contain sodium azide and gentamicin sulfate.\nCORTISOL-125 I：2 x 52 mL\nThis radioactive material contains less than 3 microcuries per vial on the date of calibration. 1.0 mL of this material will provide approximately 45,000 cpm on calibration day, using a counter with 75% efficiency.收合

醫器規格

# 07-221102：100 Tubes

限制項目

輸入須附同意書（每次輸入均須取得原子能委員會之同意書為憑）;;輸 入

申請商名稱

普生股份有限公司

申請商地址

新竹縣寶山鄉新竹科學園區創新一路6號

申請商統一編號

47299918

製造商名稱

MP BIOMEDICALS DIAGNOSTICS DIVISION

製造廠廠址

29525 FOUNTAIN PARKWAY, CLEVELAND, OH 44139, U.S.A.

製造廠國別

US

異動日期

2023/10/11

製造許可登錄編號

QSD9348

建立時間 2026-09-22 15:59:35 · 更新時間 2026-09-22 15:59:35