常盈黃體脂酮檢驗試劑

醫療器材許可證 · 許可證字號：衛署醫器輸字第015950號

許可證字號

衛署醫器輸字第015950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

DHAS0601595001

中文品名

常盈黃體脂酮檢驗試劑

英文品名

DSL Progesterone RIA

效能

利用放射性免疫定量方法檢測血清或血漿中的黃體脂酮蒙荷爾蒙。

醫器主類別一

A 臨床化學及臨床毒理學

醫器次類別一

A.1620 黃體脂酮試驗系統

主成分略述

Progesterone Standards: \nOne vial, labeled A, containing 0 ng/mL and five vials, labeled B-F, containing concentrations of\napproximately 0.3, 1.0, 5.0, 20.0, and 60.0 ng/mL (1.0-190.8 nmol/L) of progesterone in serum w…展開

Progesterone Standards: \nOne vial, labeled A, containing 0 ng/mL and five vials, labeled B-F, containing concentrations of\napproximately 0.3, 1.0, 5.0, 20.0, and 60.0 ng/mL (1.0-190.8 nmol/L) of progesterone in serum with sodium\nazide as a preservative. \n* DSL-3900 (500 Tubes) contains three sets of Standards.\nProgesterone [I-125] Reagent: \nOne bottle (DSL-3900), 55 mL each, containing <5 μCi (185 kBq) of [I-125]-labeled progesterone in a\nprotein-based buffer with sodium benzoate as a preservative. \n* DSL-3900 (500 Tubes) contains five vials of reagent.\nAnti-Progesterone-Coated Tubes: \n One hundred (100) or five hundred (500) plastic tubes with rabbit anti-progesterone immunoglobulin\nimmobilized to the inside wall of each tube. \nProgesterone Controls: \nTwo vials, Levels I and II, containing low and high concentrations of progesterone in serum with sodium azide as a preservative. \nDSL-3900 (500 Tubes) contains three sets of Controls.\n收合

醫器規格

DSL-3900: 100 tubesDSL-3900-5: 500 tubes

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 15:59:32 · 更新時間 2026-09-22 15:59:32