常盈無需選粹胰島素樣生長因子I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
中文品名常盈無需選粹胰島素樣生長因子I酵素免疫試劑組的英文品名是DSL ACTIVE NON-Extraction IGF-I ELISA, 許可證字號是衛署醫器輸字第016209號, 有效日期是2011/03/23, 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, 效能是定量測定人體血清或血漿中的IGF-1。, 主成分略述是H. Wash Concentrate: containing buffered saline with a nonionic detergent.\nI. Sample Buffer I: containing sample buffer with a non-mercury preservati..., 醫器規格是DSL-10-2800: 96 wells, 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016209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 | 2011/03/23 |
| 發證日期 | 2006/03/23 |
| 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 | DHA00601620909 |
| 中文品名 | 常盈無需選粹胰島素樣生長因子I酵素免疫試劑組 |
| 英文品名 | DSL ACTIVE NON-Extraction IGF-I ELISA |
| 效能 | 定量測定人體血清或血漿中的IGF-1。 |
| 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.1370 人體生長激素試驗系統 |
| 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 | H. Wash Concentrate: containing buffered saline with a nonionic detergent.\nI. Sample Buffer I: containing sample buffer with a non-mercury preservative.\nJ. Sample Buffer II: containing sample buffer with a non-mercury preservative.\nK. Stopping Solution: containing 0.2 M sulfuric acid.\n A. Anti-IGF-1-Coated Microttitration Strips: One stripholder containing 96 microtitration wells coated with anti-IGF-1 antibody.\nB. IGF-1 Standard A/Sample Diluent: containing 0 ng/ml IGF-1 in protein-based (BSA) buffer with a non-mercury preservative.\nC. IGF-1 Standard B-F: containing concentrations of approximately 10, 50, 140, 300, and 600 ng/ml IGF-1 (synthetic) in a protein-based (BSA) buffer with a non-mercury preservative.\nD. IGF-1 Controls: containing low and high concentrations of IGF-1 in a protein-based (BSA) buffer with non-mercury preservative.\nE. Assay Buffer B: containing a protein-based (BSA) buffer with a non-mercury preservative.\nF. IGF-1 Antibody-Enzyme Conjugate Concentrate: containing anti-IGF-1 antibody conjugated to the enzyme horseradish peroxidase in a protein-based (BSA) buffer with a non-mercury preservative.\nG. TMB Chromogen Solution: containing a solution of tetramethylbenzidine (TMB) in buffer with hydrogen peroxide.\n |
| 醫器規格 | DSL-10-2800: 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016209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2011/03/23 |
發證日期2006/03/23 |
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DHA00601620909 |
中文品名常盈無需選粹胰島素樣生長因子I酵素免疫試劑組 |
英文品名DSL ACTIVE NON-Extraction IGF-I ELISA |
效能定量測定人體血清或血漿中的IGF-1。 |
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.1370 人體生長激素試驗系統 |
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H. Wash Concentrate: containing buffered saline with a nonionic detergent.\nI. Sample Buffer I: containing sample buffer with a non-mercury preservative.\nJ. Sample Buffer II: containing sample buffer with a non-mercury preservative.\nK. Stopping Solution: containing 0.2 M sulfuric acid.\n A. Anti-IGF-1-Coated Microttitration Strips: One stripholder containing 96 microtitration wells coated with anti-IGF-1 antibody.\nB. IGF-1 Standard A/Sample Diluent: containing 0 ng/ml IGF-1 in protein-based (BSA) buffer with a non-mercury preservative.\nC. IGF-1 Standard B-F: containing concentrations of approximately 10, 50, 140, 300, and 600 ng/ml IGF-1 (synthetic) in a protein-based (BSA) buffer with a non-mercury preservative.\nD. IGF-1 Controls: containing low and high concentrations of IGF-1 in a protein-based (BSA) buffer with non-mercury preservative.\nE. Assay Buffer B: containing a protein-based (BSA) buffer with a non-mercury preservative.\nF. IGF-1 Antibody-Enzyme Conjugate Concentrate: containing anti-IGF-1 antibody conjugated to the enzyme horseradish peroxidase in a protein-based (BSA) buffer with a non-mercury preservative.\nG. TMB Chromogen Solution: containing a solution of tetramethylbenzidine (TMB) in buffer with hydrogen peroxide.\n |
醫器規格DSL-10-2800: 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) |
常盈無需選粹胰島素樣生長因子I酵素免疫試劑組地圖 [ 導航 ]
常盈無需選粹胰島素樣生長因子I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