常盈總甲狀腺素檢驗試劑

醫療器材許可證 · 許可證字號：衛署醫器輸字第015951號

許可證字號

衛署醫器輸字第015951號

註銷狀態

已註銷

註銷日期

2012/11/26

註銷理由

許可證已逾有效期

有效日期

2011/01/26

發證日期

2006/01/26

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHAS0601595100

中文品名

常盈總甲狀腺素檢驗試劑

英文品名

DSL Thyroxine RIA

效能

利用放射性免疫定量方法檢測血清中總甲狀腺素濃度。

醫器主類別一

A 臨床化學及臨床毒理學

醫器次類別一

A.1700 總甲狀腺素試驗系統

主成分略述

T4 Standards:One vial, 2 mL, labeled A, containing 0.0 μg/dL and six vials, 0.5 mL each, labeled B-G, containing concentrations of approximately 1.0, 2.5, 5.0, 10.0, 25.0, 50.0 μg/dL T4 in serum with sodium azide as a pr…展開

T4 Standards:One vial, 2 mL, labeled A, containing 0.0 μg/dL and six vials, 0.5 mL each, labeled B-G, containing concentrations of approximately 1.0, 2.5, 5.0, 10.0, 25.0, 50.0 μg/dL T4 in serum with sodium azide as a preservative. *DSL-3200 (500 tubes) contains three sets of standards.T4 [I-125] Reagent: One bottle, 22 mL, containing < 5 μCi (185 kBq) of [I-125]-labeled T4 in a protein-based (BSA) buffer with sodium azide as a preservative. *DSL-3200 (500 Tubes) contains five bottles of reagent.Anti-T4-Coated Tubes: One hundred (100) plastic tubes with anti-T4 antibody immobilized to the inside wall of each tube. *DSL-3200 (500 Tubes) contains five (500) hundred plastic tubes.T4 Controls:Two vials, 0.5 mL each, Levels I and II, containing low and high concentrations of T4 in the euthyroid range in serum with sodium azide as a preservative. *DSL-3200 (500 Tubes) contains three sets of controls.Wash Concentrate:One bottle, 18 mL, containing buffered saline with a nonionic detergent. Dilute 50-fold with deioni收合

醫器規格

DSL-3200: 100 tubesDSL-3200-5: 500 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

常盈實業股份有限公司

申請商地址

台北市北投區永興路一段49號

申請商統一編號

96926140

製造商名稱

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

製造廠廠址

445 MEDICAL CENTER BOULEVARD WEBSTER, TEXAS 77598 U.S.A.

製造廠國別

US

異動日期

2012/11/27

建立時間 2026-09-22 15:59:32 · 更新時間 2026-09-22 15:59:32