"必帝" CD34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"必帝" CD34試劑的英文品名是"BD" CD34 Reagent, 許可證字號是衛署醫器輸字第015936號, 有效日期是2011/01/24, 註銷狀態是已註銷, 註銷日期是2012/10/26, 註銷理由是許可證已逾有效期, 許可證種類是09, 效能是CD34[抗原是單鏈穿膜醣蛋白質，分子量105至120仟道耳吞。此抗原與人類造血幹細胞有關，為一特定分化期白血球抗原。, 主成分略述是Clone My10: The monoclonal antibody is supplied as 100 ug purified immunoglobulin in 2.0 mL (50 ug/mL) of phosphate-buffered saline (PBS).Clone 8G12: ..., 醫器規格是#340859, #340862, #340668, #340669, #340666, #347213, #348801, #340667, 限制項目是輸 入, 申請商名稱是美商必帝股份有限公司台灣分公司.
| 許可證字號 | 衛署醫器輸字第015936號 |
| 註銷狀態 | 已註銷 |
| 註銷日期 | 2012/10/26 |
| 註銷理由 | 許可證已逾有效期 |
| 有效日期 | 2011/01/24 |
| 發證日期 | 2006/01/24 |
| 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 | DHA00601593609 |
| 中文品名 | "必帝" CD34試劑 |
| 英文品名 | "BD" CD34 Reagent |
| 效能 | CD34[抗原是單鏈穿膜醣蛋白質，分子量105至120仟道耳吞。此抗原與人類造血幹細胞有關，為一特定分化期白血球抗原。 |
| 劑型 | (空) |
| 包裝 | (空) |
| 醫器主類別一 | B 血液學、病理學及基因學 |
| 醫器次類別一 | B.4020 分析特定試劑 |
| 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 | Clone My10: The monoclonal antibody is supplied as 100 ug purified immunoglobulin in 2.0 mL (50 ug/mL) of phosphate-buffered saline (PBS).Clone 8G12: The monoclonal antibody is supplied as 50 ug purified immunoglobulin in 2.0 mL(25 ug/mL) of PBS. The FITC and PE conjugates are each supplied as 50 ug in 2.0 mL (25 ug/mL) of PBS. The PerCP conjugate is supplied as 50 ug in 1.0 mL (50 ug/mL) of PBS. The PerCP-Cy5.5 conjugate is supplied as 12.5 ug in 1.0 mL (12.5 ug/mL) of PBS. The PE-Cy7 conjugate is supplied as 25 ug in 0.5 mL (50 ug/mL) of PBS. The APC conjugate is supplied as 50 ug in 0.5 mL (100 ug/mL) of PBS. PBS contains gelatin and 0.1% sodium azide. Twenty microliters (20 uL) of the monoclonal antibody, the FITC-, PE-, PerCP, or the PerCP-Cy5.5–conjugated antibody stains 106 peripheral blood mononuclear cells (PBMCs). Five microliters (5 uL) of the PE-Cy7– or the APC-conjugated antibody stains 106 PBMCs. |
| 醫器規格 | #340859, #340862, #340668, #340669, #340666, #347213, #348801, #340667 |
| 限制項目 | 輸 入 |
| 申請商名稱 | 美商必帝股份有限公司台灣分公司 |
| 申請商地址 | 台北市信義區忠孝東路四段560號8樓 |
| 申請商統一編號 | 22419113 |
| 製造商名稱 | BD BIOSCIENCES IMMUNOCYTOMETRY SYSTEMS, A UNIT OF BECTON, DICKINSON AND COMPANY |
| 製造廠廠址 | 2350 QUME DRIVE, SAN JOSE, CA95131, U.S.A. |
| 製造廠公司地址 | (空) |
| 製造廠國別 | US |
| 製程 | (空) |
| 異動日期 | 2012/10/30 |
| 製造許可登錄編號 | (空) |
許可證字號衛署醫器輸字第015936號 |
註銷狀態已註銷 |
註銷日期2012/10/26 |
註銷理由許可證已逾有效期 |
有效日期2011/01/24 |
發證日期2006/01/24 |
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DHA00601593609 |
中文品名"必帝" CD34試劑 |
英文品名"BD" CD34 Reagent |
效能CD34[抗原是單鏈穿膜醣蛋白質，分子量105至120仟道耳吞。此抗原與人類造血幹細胞有關，為一特定分化期白血球抗原。 |
劑型(空) |
包裝(空) |
醫器主類別一B 血液學、病理學及基因學 |
醫器次類別一B.4020 分析特定試劑 |
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Clone My10: The monoclonal antibody is supplied as 100 ug purified immunoglobulin in 2.0 mL (50 ug/mL) of phosphate-buffered saline (PBS).Clone 8G12: The monoclonal antibody is supplied as 50 ug purified immunoglobulin in 2.0 mL(25 ug/mL) of PBS. The FITC and PE conjugates are each supplied as 50 ug in 2.0 mL (25 ug/mL) of PBS. The PerCP conjugate is supplied as 50 ug in 1.0 mL (50 ug/mL) of PBS. The PerCP-Cy5.5 conjugate is supplied as 12.5 ug in 1.0 mL (12.5 ug/mL) of PBS. The PE-Cy7 conjugate is supplied as 25 ug in 0.5 mL (50 ug/mL) of PBS. The APC conjugate is supplied as 50 ug in 0.5 mL (100 ug/mL) of PBS. PBS contains gelatin and 0.1% sodium azide. Twenty microliters (20 uL) of the monoclonal antibody, the FITC-, PE-, PerCP, or the PerCP-Cy5.5–conjugated antibody stains 106 peripheral blood mononuclear cells (PBMCs). Five microliters (5 uL) of the PE-Cy7– or the APC-conjugated antibody stains 106 PBMCs. |
醫器規格#340859, #340862, #340668, #340669, #340666, #347213, #348801, #340667 |
限制項目輸 入 |
申請商名稱美商必帝股份有限公司台灣分公司 |
申請商地址台北市信義區忠孝東路四段560號8樓 |
申請商統一編號22419113 |
製造商名稱BD BIOSCIENCES IMMUNOCYTOMETRY SYSTEMS, A UNIT OF BECTON, DICKINSON AND COMPANY |
製造廠廠址2350 QUME DRIVE, SAN JOSE, CA95131, U.S.A. |
製造廠公司地址(空) |
製造廠國別US |
製程(空) |
異動日期2012/10/30 |
製造許可登錄編號(空) |
"必帝" CD34試劑地圖 [ 導航 ]
"必帝" CD34試劑的地址位於
台北市信義區忠孝東路四段560號8樓