美堅迪爾埃狄各新試劑
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名美堅迪爾埃狄各新試劑的英文品名是MGC DRI Digoxin Assay, 許可證字號是衛署醫器輸字第021355號, 有效日期是2025/07/19, 許可證種類是09, 效能是定量測定人類血清及血漿中的毛地黃素(digoxin)含量。, 主成分略述是Antibody Reagent Contains: monoclonal anti-digoxin antibody in a buffer solution with sodium azide as a preservative. Microparticles Reagent Contains:..., 醫器規格是#1669 DRI Digoxin Assay (25 ml,8 ml kit)。, 限制項目是輸 入, 申請商名稱是醫全實業股份有限公司.
許可證字號 | 衛署醫器輸字第021355號 |
註銷狀態 | (空) |
註銷日期 | (空) |
註銷理由 | (空) |
有效日期 | 2025/07/19 |
發證日期 | 2010/07/19 |
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 | DHA00602135501 |
中文品名 | 美堅迪爾埃狄各新試劑 |
英文品名 | MGC DRI Digoxin Assay |
效能 | 定量測定人類血清及血漿中的毛地黃素(digoxin)含量。 |
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.3320 毛地黃毒素試驗系統 |
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 | Antibody Reagent Contains: monoclonal anti-digoxin antibody in a buffer solution with sodium azide as a preservative. Microparticles Reagent Contains: digoxin coated microparticles suspension in an aqueous solution with sodium azide as a preservative. Calibrators: DRI Digoxin Negative Calibrator 1 x 5 mL (Contains 5 mL buffer solution with sodium azide as a preservative); DRI Digoxin 0.5 ng/mL Calibrator 1 x 2 mL (Contains 0.5 ng/mL Digoxin in buffer solution with sodium azide as a preservative); DRI Digoxin 1.0 ng/mL Calibrator 1 x 2 mL (Contains 1.0 ng/mL Digoxin in buffer solution with sodium azide as a preservative); DRI Digoxin 2.0 ng/mL Calibrator 1 x 2 mL (Contains 2.0 ng/mL Digoxin in buffer solution with sodium azide as a preservative); DRI Digoxin 3.0 ng/mL Calibrator 1 x 2 mL (Contains 3.0 ng/mL Digoxin in buffer solution with sodium azide as a preservative); DRI Digoxin 5.0 ng/mL Calibrator 1 x 2 mL (Contains 5.0 ng/mL Digoxin in buffer solution with sodium azide as a preservative). |
醫器規格 | #1669 DRI Digoxin Assay (25 ml,8 ml kit)。 |
限制項目 | 輸 入 |
申請商名稱 | 醫全實業股份有限公司 |
申請商地址 | 新北市新店區寶橋路235巷6弄2號9樓 |
申請商統一編號 | 09436650 |
製造商名稱 | MICROGENICS CORPORATION |
製造廠廠址 | 46500 KATO ROAD, FREMONT, CA94538, USA |
製造廠公司地址 | (空) |
製造廠國別 | US |
製程 | (空) |
異動日期 | 2022/11/04 |
製造許可登錄編號 | QSD9925 |
許可證字號衛署醫器輸字第021355號 |
註銷狀態(空) |
註銷日期(空) |
註銷理由(空) |
有效日期2025/07/19 |
發證日期2010/07/19 |
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DHA00602135501 |
中文品名美堅迪爾埃狄各新試劑 |
英文品名MGC DRI Digoxin Assay |
效能定量測定人類血清及血漿中的毛地黃素(digoxin)含量。 |
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.3320 毛地黃毒素試驗系統 |
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Antibody Reagent Contains: monoclonal anti-digoxin antibody in a buffer solution with sodium azide as a preservative. Microparticles Reagent Contains: digoxin coated microparticles suspension in an aqueous solution with sodium azide as a preservative. Calibrators: DRI Digoxin Negative Calibrator 1 x 5 mL (Contains 5 mL buffer solution with sodium azide as a preservative); DRI Digoxin 0.5 ng/mL Calibrator 1 x 2 mL (Contains 0.5 ng/mL Digoxin in buffer solution with sodium azide as a preservative); DRI Digoxin 1.0 ng/mL Calibrator 1 x 2 mL (Contains 1.0 ng/mL Digoxin in buffer solution with sodium azide as a preservative); DRI Digoxin 2.0 ng/mL Calibrator 1 x 2 mL (Contains 2.0 ng/mL Digoxin in buffer solution with sodium azide as a preservative); DRI Digoxin 3.0 ng/mL Calibrator 1 x 2 mL (Contains 3.0 ng/mL Digoxin in buffer solution with sodium azide as a preservative); DRI Digoxin 5.0 ng/mL Calibrator 1 x 2 mL (Contains 5.0 ng/mL Digoxin in buffer solution with sodium azide as a preservative). |
醫器規格#1669 DRI Digoxin Assay (25 ml,8 ml kit)。 |
限制項目輸 入 |
申請商名稱醫全實業股份有限公司 |
申請商地址新北市新店區寶橋路235巷6弄2號9樓 |
申請商統一編號09436650 |
製造商名稱MICROGENICS CORPORATION |
製造廠廠址46500 KATO ROAD, FREMONT, CA94538, USA |
製造廠公司地址(空) |
製造廠國別US |
製程(空) |
異動日期2022/11/04 |
製造許可登錄編號QSD9925 |
美堅迪爾埃狄各新試劑地圖 [ 導航 ]
美堅迪爾埃狄各新試劑的地址位於
新北市新店區寶橋路235巷6弄2號9樓