常盈促腎上腺皮質素放射免疫分析法
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名常盈促腎上腺皮質素放射免疫分析法的英文品名是DSL ACTH RIA, 許可證字號是衛署醫器輸字第015918號, 有效日期是2011/01/23, 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, 效能是利用放射性免疫定量方法檢測血漿中的促腎上腺皮質素。, 主成分略述是A. ACTH Standards: (Lyophilized) One vial, labeled A, containing 0 pg/mL and five vials, labeled B-F, containing concentrations of approximately 25, 1..., 醫器規格是DSL-2300: 100 tube, 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015918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 | 2011/01/23 |
| 發證日期 | 2006/01/23 |
| 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 | DHAS0601591802 |
| 中文品名 | 常盈促腎上腺皮質素放射免疫分析法 |
| 英文品名 | DSL ACTH RIA |
| 效能 | 利用放射性免疫定量方法檢測血漿中的促腎上腺皮質素。 |
| 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.1025 促腎上腺皮質荷爾蒙試驗系統 |
| 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 | A. ACTH Standards: (Lyophilized) One vial, labeled A, containing 0 pg/mL and five vials, labeled B-F, containing concentrations of approximately 25, 100, 200, 500 and 1000 pg/mL (5.5 -220.0 pmol/L) ACTH in a protein-based buffer with sodium azide as a preservative. Refer to vial labels for exact concentrations. Store unopened at 2-8°C until expiration date. Reconstitute Standard A with 5 mL of ACTH Buffer. Reconstitute Standards B-F with 1 mL of ACTH Assay Buffer. Use immediately upon reconstitution. Discard after use. STANDARDIZATION NOTE: The ACTH Standards & Controls have been calibrated to the World Health Organization International Reference Reagent for ACTH (code 74/555) and performance verified by immunoassay. B. ACTH [I-125] Reagent: (Lyophilized) (RED) One vial, containing < 5 μCi (185 kBq) of [I-125]-labeled ACTH in a buffer with a protein stabilizer and sodium azide as a preservative. Store unopened at 2-8°C until expiration date. Reconstitute with 11 mL ACTH Assay Buffer. Use immediately upon reco |
| 醫器規格 | DSL-2300: 100 tube |
| 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015918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2011/01/23 |
發證日期2006/01/23 |
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DHAS0601591802 |
中文品名常盈促腎上腺皮質素放射免疫分析法 |
英文品名DSL ACTH RIA |
效能利用放射性免疫定量方法檢測血漿中的促腎上腺皮質素。 |
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.1025 促腎上腺皮質荷爾蒙試驗系統 |
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A. ACTH Standards: (Lyophilized) One vial, labeled A, containing 0 pg/mL and five vials, labeled B-F, containing concentrations of approximately 25, 100, 200, 500 and 1000 pg/mL (5.5 -220.0 pmol/L) ACTH in a protein-based buffer with sodium azide as a preservative. Refer to vial labels for exact concentrations. Store unopened at 2-8°C until expiration date. Reconstitute Standard A with 5 mL of ACTH Buffer. Reconstitute Standards B-F with 1 mL of ACTH Assay Buffer. Use immediately upon reconstitution. Discard after use. STANDARDIZATION NOTE: The ACTH Standards & Controls have been calibrated to the World Health Organization International Reference Reagent for ACTH (code 74/555) and performance verified by immunoassay. B. ACTH [I-125] Reagent: (Lyophilized) (RED) One vial, containing < 5 μCi (185 kBq) of [I-125]-labeled ACTH in a buffer with a protein stabilizer and sodium azide as a preservative. Store unopened at 2-8°C until expiration date. Reconstitute with 11 mL ACTH Assay Buffer. Use immediately upon reco |
醫器規格DSL-2300: 100 tube |
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) |
常盈促腎上腺皮質素放射免疫分析法地圖 [ 導航 ]
常盈促腎上腺皮質素放射免疫分析法的地址位於
台北市北投區永興路一段49號