常盈完整副甲狀腺激素試劑組

醫療器材許可證 · 許可證字號：衛署醫器輸字第015947號

許可證字號

衛署醫器輸字第015947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

2011/01/25

發證日期

2006/01/25

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHAS0601594709

中文品名

常盈完整副甲狀腺激素試劑組

英文品名

DSL INTACT PTH IRMA

效能

提供血清或血漿完整PTH(I-PTH)的定量測定。

醫器主類別一

A 臨床化學及臨床毒理學

醫器次類別一

A.1545 副甲狀腺激素試驗系統

主成分略述

I-PTH Standards:\nOne vial, 5 mL, labeled A, containing 0 pg/mL I-PTH and six vials, 1 mL each, labeled B-G, containing\napproximate concentrations of 10, 30, 100, 250, 750 and 2000 pg/mL human PTH (1-84) in a protein-ba…展開

I-PTH Standards:\nOne vial, 5 mL, labeled A, containing 0 pg/mL I-PTH and six vials, 1 mL each, labeled B-G, containing\napproximate concentrations of 10, 30, 100, 250, 750 and 2000 pg/mL human PTH (1-84) in a protein-based\nbuffer with a non-mercury preservative.\n* DSL-8000 (500 Tubes) contains three sets of standards\nAnti-PTH-Coated Tubes: \nOne hundred (100) plastic tubes with Anti-PTH (39-84) immobilized to the inside wall of each tube. \n* DSL-8000 (500 Tubes) contains five hundred (500) plastic tubes.\n Anti-PTH [I-125] Reagent: \nTwo vials in DSL-8000 (100 Tubes) , 5.5 mL each, containing <10 μCi (370 kBq) per vial of [I-125]-labeled\nanti-PTH (1-34) in a protein-stabilized buffer and sodium azide as a preservative. \n* DSL-8000 (500 Tubes) contains ten (10) vials of reagent.\nI-PTH Controls:\nTwo vials containing low and high concentrations of I-PTH in a protein-based buffer with a non-mercury\npreservative.\n* DSL-8000 (500 Tubes) contains three sets of controls.\nWash Concentrate:\nOne bottle, 100 mL, containing buffered saline with a nonionic detergent. \n* DSL-8000 (500 Tubes) contains five bottles of wash concentrate.\n收合

醫器規格

DSL-8000-5: 500 testsDSL-8000: 100 tests

限制項目

輸 入;;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）

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 15:59:35 · 更新時間 2026-09-22 15:59:35