常盈抑制素A酵素免疫試劑組

醫療器材許可證 · 許可證字號：衛署醫器輸字第015962號

許可證字號

衛署醫器輸字第015962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

2011/02/03

發證日期

2006/02/03

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHA00601596200

中文品名

常盈抑制素A酵素免疫試劑組

英文品名

DSL Inhibin A ELISA

效能

提供人血清或血漿中二聚抑制素A的定量檢測。

醫器主類別一

A 臨床化學及臨床毒理學

醫器次類別一

A.1260 雌二醇試驗系統

主成分略述

Standards.\nInhibin A Controls:\nOne set of Controls, 1.0 mL each, Levels I and II, containing low and high concentrations of Dimeric Inhibin A in fetal bovine serum with a non-mercury preservative. \n*DSL-10-28100 (4-pl…展開

Standards.\nInhibin A Controls:\nOne set of Controls, 1.0 mL each, Levels I and II, containing low and high concentrations of Dimeric Inhibin A in fetal bovine serum with a non-mercury preservative. \n*DSL-10-28100 (4-plate) contains two (2) sets of Controls.\n\nE. Inhibin A Sample Buffer A:\nOne bottle, 10 mL, containing a protein-based buffer with a non-mercury preservative. Store at 2-8°C until\nexpiration date.\n*DSL-10-28100-4 contains one (1)-30 mL bottle.\nF. Inhibin A Sample Buffer B:\nOne bottle, 10 mL, containing a protein-based buffer with a non-mercury preservative. Store at 2-8°C until\nexpiration date.\n*DSL-10-28100 (4-plate) contains one (1)-30 mL bottle.\nG. Inhibin A Antibody-Enzyme Conjugate Concentrate:\nOne vial, containing 0.6 mL of a solution of anti-Inhibin α-subunit antibody conjugated to horseradish\nperoxidase in a protein-based buffer with a non-mercury preservative. Dilute prior to use in Conjugate\nDiluent. Store at 2-8°C until expiration date.\n*DSL-10-28100 (4-plate) contains f Anti-Inhibin A-Coated Microtitration Strips:\nOne stripholders, each containing 96 polystyrene microtiter wells coated with anti-Inhibin βA subunit antibody immobilized to the inside wall of each well. *DSL-10-28100 (4-plate) contains four (4) stripholders.\nInhibin A Standard A/Sample Diluent:\nOne vial, 2 mL each, labeled A, containing 0 pg/mL dimeric Inhibin A in fetal bovine serum with a nonmercury preservative. \n*DSL-10-28100 (4-plate) contains two (2) vials.\nInhibin A Standards:\nOne set of Standards, 1 mL each, labeled B-G, containing concentrations of approximately 10, 30, 100, 250, 500, and 1000 pg/mL dimeric Inhibin A in fetal bovine serum with a non-mercury preservative. \n*DSL-10-28100 (4-plate) contains two (2) sets of收合

醫器規格

DSL-10-28100-1: 1 x 96 wellsDSL-10-28100-4: 4 x 96 wells

限制項目

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