常盈卵泡刺激激素檢驗試劑
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名常盈卵泡刺激激素檢驗試劑的英文品名是DSL FSH IRMA, 許可證字號是衛署醫器輸字第015861號, 有效日期是2011/01/10, 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卵泡刺激激素荷爾蒙。, 主成分略述是FSH Standards:One vial, 2.0 mL, labeled A, containing 0 mIU/mL and six vials, 1.0 mL each, labeled B-G, containing concentrations of approximately 1.5..., 醫器規格是DSL-4700 100 tubes、DSL-4700-5 500 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015861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 | 2011/01/10 |
| 發證日期 | 2006/01/10 |
| 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 | DHAS0601586102 |
| 中文品名 | 常盈卵泡刺激激素檢驗試劑 |
| 英文品名 | DSL FSH IRMA |
| 效能 | 利用放射性免疫定量方法檢測血清中卵泡刺激激素荷爾蒙。 |
| 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 | (空) |
| 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 | FSH Standards:One vial, 2.0 mL, labeled A, containing 0 mIU/mL and six vials, 1.0 mL each, labeled B-G, containing concentrations of approximately 1.5, 4.5, 15.0, 45.0, 150.0 and 450.0 mIU/mL FSH (from human pituitary gland) in porcine serum with sodium azide as a preservative.*DSL-4700 (500 Tubes) contains three sets of calibrators.Anti-FSH [I-125] Reagent:One vial, 11 mL each, containing < 10 μCi (370 kBq) of [I-125]-labeled anti-FSH in a protein-based (BSA) buffer with sodium azide as a preservative.*DSL-4700 (500 Tubes) contains five vials of reagent.Anti-FSH-Coated Tubes:One hundred (100) plastic tubes or five hundred plastic tubes with anti-FSH antibody immobilized to the inside wall of each tube. FSH Controls:Two vials, 1.0 mL each, levels I and II, containing low and high concentrations of FSH (from human pituitary gland) in porcine serum with sodium azide as a preservative.Wash Concentrate:One bottle, 100 mL, containing wash concentrate with sodium azide as a preservative.*DSL-4700 (500 Tubes) contai |
| 醫器規格 | DSL-4700 100 tubes、DSL-4700-5 500 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015861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2011/01/10 |
發證日期2006/01/10 |
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DHAS0601586102 |
中文品名常盈卵泡刺激激素檢驗試劑 |
英文品名DSL FSH IRMA |
效能利用放射性免疫定量方法檢測血清中卵泡刺激激素荷爾蒙。 |
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(空) |
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FSH Standards:One vial, 2.0 mL, labeled A, containing 0 mIU/mL and six vials, 1.0 mL each, labeled B-G, containing concentrations of approximately 1.5, 4.5, 15.0, 45.0, 150.0 and 450.0 mIU/mL FSH (from human pituitary gland) in porcine serum with sodium azide as a preservative.*DSL-4700 (500 Tubes) contains three sets of calibrators.Anti-FSH [I-125] Reagent:One vial, 11 mL each, containing < 10 μCi (370 kBq) of [I-125]-labeled anti-FSH in a protein-based (BSA) buffer with sodium azide as a preservative.*DSL-4700 (500 Tubes) contains five vials of reagent.Anti-FSH-Coated Tubes:One hundred (100) plastic tubes or five hundred plastic tubes with anti-FSH antibody immobilized to the inside wall of each tube. FSH Controls:Two vials, 1.0 mL each, levels I and II, containing low and high concentrations of FSH (from human pituitary gland) in porcine serum with sodium azide as a preservative.Wash Concentrate:One bottle, 100 mL, containing wash concentrate with sodium azide as a preservative.*DSL-4700 (500 Tubes) contai |
醫器規格DSL-4700 100 tubes、DSL-4700-5 500 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) |
常盈卵泡刺激激素檢驗試劑地圖 [ 導航 ]
常盈卵泡刺激激素檢驗試劑的地址位於
台北市北投區永興路一段49號