常盈抑制素A酵素免疫試劑組
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名常盈抑制素A酵素免疫試劑組的英文品名是DSL Inhibin A ELISA, 許可證字號是衛署醫器輸字第015962號, 有效日期是2011/02/03, 註銷狀態是已註銷, 註銷日期是2012/11/26, 註銷理由是許可證已逾有效期, 許可證種類是09, 效能是提供人血清或血漿中二聚抑制素A的定量檢測。, 主成分略述是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 fet..., 醫器規格是DSL-10-28100-1: 1 x 96 wellsDSL-10-28100-4: 4 x 96 well, 限制項目是輸 入, 申請商名稱是常盈實業股份有限公司.
| 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 |
| 舊證字號 | (空) |
| 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。 |
| 劑型 | (空) |
| 包裝 | (空) |
| 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 |
| 醫器主類別二 | (空) |
| 醫器次類別二 | (空) |
| 醫器主類別三 | (空) |
| 醫器次類別三 | (空) |
| 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-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 |
| 醫器規格 | DSL-10-28100-1: 1 x 96 wellsDSL-10-28100-4: 4 x 96 well |
| 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. |
| 製造廠公司地址 | (空) |
| 製造廠國別 | US |
| 製程 | (空) |
| 異動日期 | 2012/11/27 |
| 製造許可登錄編號 | (空) |
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 |
舊證字號(空) |
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。 |
劑型(空) |
包裝(空) |
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 |
醫器主類別二(空) |
醫器次類別二(空) |
醫器主類別三(空) |
醫器次類別三(空) |
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-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 |
醫器規格DSL-10-28100-1: 1 x 96 wellsDSL-10-28100-4: 4 x 96 well |
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. |
製造廠公司地址(空) |
製造廠國別US |
製程(空) |
異動日期2012/11/27 |
製造許可登錄編號(空) |
常盈抑制素A酵素免疫試劑組地圖 [ 導航 ]
常盈抑制素A酵素免疫試劑組的地址位於
台北市北投區永興路一段49號