常盈總三碘甲狀腺素檢驗試劑
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名常盈總三碘甲狀腺素檢驗試劑的英文品名是DSL T3 RIA, 許可證字號是衛署醫器輸字第015866號, 有效日期是2011/01/11, 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, 效能是利用放射性免疫定量方法檢測血清中總三碘甲狀腺素荷爾蒙。, 主成分略述是T3 Standards:One vial, 1.0 ml, labeled A, containing 0 ng/dL and six vials, 0.5 mL each, labeled B-G, containing concentrations of approximately 25.0,..., 醫器規格是DSL-3100 (100 tubes)、DSL-3100-5 (500 tubes), 限制項目是輸入須附同意書（每次輸入均須取得原子能委員會之同意書為憑）;;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015866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 | 2011/01/11 |
| 發證日期 | 2006/01/11 |
| 許可證種類 | 09 |
| 舊證字號 | (空) |
| 醫療器材級數 | (空) |
| 通關簽審文件編號 | DHAS0601586609 |
| 中文品名 | 常盈總三碘甲狀腺素檢驗試劑 |
| 英文品名 | DSL T3 RIA |
| 效能 | 利用放射性免疫定量方法檢測血清中總三碘甲狀腺素荷爾蒙。 |
| 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.1710 總三碘甲狀腺素試驗系統 |
| 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 | T3 Standards:One vial, 1.0 ml, labeled A, containing 0 ng/dL and six vials, 0.5 mL each, labeled B-G, containing concentrations of approximately 25.0, 50.0, 100.0, 250.0, 500.0 and 1000.0 ng/dL T3 in huamn serum with sodium azide as a preservative.*DSL-3100 (500 Tubes) contains 3 sets of Standards. T3 [I-125] Reagent:One bottle in DSL-3100 (100 Tubes), 22 mL each, containing < 5 μCi (185 kBq) of [I-125]-labeled T3 in a protein-based (BSA) buffer with sodium azide as a preservative.*DSL-3100 (500 Tubes) contains five bottles of reagent. GAMG-Coated Tubes:One hundred (100) plastic tubes with goat anti-mouse gamma globulin immobilized to the inside wall of each tube.*DSL-3100 (500 Tubes) contains 500 tubes. Anti-T3 Antibody:One vial in DSL-3100 (100 Tubes), 11 mL each, containing anti-T3 mouse monoclonal antibody in a protein-based (BSA) buffer with sodium sodium azide as a preservative.*DSL-3100 (500 Tubes) contains five vials of antibody.T3 Controls:Two vials, 0.5 mL each, Level I and II, containing low and high concentrations of T3 in human serum with sodium azide as a preservative.Wash Concentrate: One bottle, 18 mL in DSL-3100 (100 Tubes), containing a concentrated buffered saline solution with sodium azide as preservative. *DSL-3100 (500 Tubes) contains one 90 mL-bottle of wash concentrate. |
| 醫器規格 | DSL-3100 (100 tubes)、DSL-3100-5 (500 tubes) |
| 限制項目 | 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）;;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015866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2011/01/11 |
發證日期2006/01/11 |
許可證種類09 |
舊證字號(空) |
醫療器材級數(空) |
通關簽審文件編號DHAS0601586609 |
中文品名常盈總三碘甲狀腺素檢驗試劑 |
英文品名DSL T3 RIA |
效能利用放射性免疫定量方法檢測血清中總三碘甲狀腺素荷爾蒙。 |
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.1710 總三碘甲狀腺素試驗系統 |
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T3 Standards:One vial, 1.0 ml, labeled A, containing 0 ng/dL and six vials, 0.5 mL each, labeled B-G, containing concentrations of approximately 25.0, 50.0, 100.0, 250.0, 500.0 and 1000.0 ng/dL T3 in huamn serum with sodium azide as a preservative.*DSL-3100 (500 Tubes) contains 3 sets of Standards. T3 [I-125] Reagent:One bottle in DSL-3100 (100 Tubes), 22 mL each, containing < 5 μCi (185 kBq) of [I-125]-labeled T3 in a protein-based (BSA) buffer with sodium azide as a preservative.*DSL-3100 (500 Tubes) contains five bottles of reagent. GAMG-Coated Tubes:One hundred (100) plastic tubes with goat anti-mouse gamma globulin immobilized to the inside wall of each tube.*DSL-3100 (500 Tubes) contains 500 tubes. Anti-T3 Antibody:One vial in DSL-3100 (100 Tubes), 11 mL each, containing anti-T3 mouse monoclonal antibody in a protein-based (BSA) buffer with sodium sodium azide as a preservative.*DSL-3100 (500 Tubes) contains five vials of antibody.T3 Controls:Two vials, 0.5 mL each, Level I and II, containing low and high concentrations of T3 in human serum with sodium azide as a preservative.Wash Concentrate: One bottle, 18 mL in DSL-3100 (100 Tubes), containing a concentrated buffered saline solution with sodium azide as preservative. *DSL-3100 (500 Tubes) contains one 90 mL-bottle of wash concentrate. |
醫器規格DSL-3100 (100 tubes)、DSL-3100-5 (500 tubes) |
限制項目輸入須附同意書（每次輸入均須取得原子能委員會之同意書為憑）;;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) |
常盈總三碘甲狀腺素檢驗試劑地圖 [ 導航 ]
常盈總三碘甲狀腺素檢驗試劑的地址位於
台北市北投區永興路一段49號