岱安韶韻環孢靈放射免疫分析試劑組
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名岱安韶韻環孢靈放射免疫分析試劑組的英文品名是DiaSorin CYCLO-Trac SP-Whole Blood RIA, 許可證字號是衛署醫器輸字第016235號, 有效日期是2016/03/28, 註銷狀態是已註銷, 註銷日期是2018/05/25, 註銷理由是許可證已逾有效期, 許可證種類是09, 效能是利用放射免疫法定量分析人體全血中之環孢靈(Cyclosporin A, Cyclosporine, Sandimmune)。, 主成分略述是CYCLO-Trac SP NSB ImmunoSep: Donkey anti-mouse serum/normal mouse serum premix is diluted in phosphate-buffered saline containing 0.08% sodium azide a..., 醫器規格是#23000: 200tubes/kit, 限制項目是輸 入;;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), 申請商名稱是新科化實業有限公司.
許可證字號 | 衛署醫器輸字第016235號 |
註銷狀態 | 已註銷 |
註銷日期 | 2018/05/25 |
註銷理由 | 許可證已逾有效期 |
有效日期 | 2016/03/28 |
發證日期 | 2006/03/28 |
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 | DHAS0601623505 |
中文品名 | 岱安韶韻環孢靈放射免疫分析試劑組 |
英文品名 | DiaSorin CYCLO-Trac SP-Whole Blood RIA |
效能 | 利用放射免疫法定量分析人體全血中之環孢靈(Cyclosporin A, Cyclosporine, Sandimmune)。 |
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.1235 環孢靈試驗系統 |
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 | CYCLO-Trac SP NSB ImmunoSep: Donkey anti-mouse serum/normal mouse serum premix is diluted in phosphate-buffered saline containing 0.08% sodium azide and a surfactant. Blue dye is added.\nCYCLO-Trac SP Calibrators (0-6): Cyclosporine-free serum cotains 0.1% sodium azide and a surfactant. Six cyclosporine calibrators, at nominal concentrations ranging from 0-1200 ng/ml, are prediluted in human serum.\nAnti-CYCLO-Trac SP ImmunoSep: Monoclonal mouse anti-cyclosporine antibody and donkey anti-mouse/normal mouse serum premix is diluted in phosphate-buffered saline containing 0.08% sodium azide and a surfactant.\n125I CYCLO-Trac SP: A derivative of cyclosporine is labeled with iodine-125 and diluted in citrate-EDTA buffer which contains 0.05% sodium azide, human serum and a surfactant. Red dye is added.\nCYCLO-Trac SP Controls (level 1 and level 2): Ranges for each lot are printed on the control vials included with each kit. 0.1% sodium azide and other stabilizers are added.\n |
醫器規格 | #23000: 200tubes/kit |
限制項目 | 輸 入;;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) |
申請商名稱 | 新科化實業有限公司 |
申請商地址 | 台北市中正區忠孝西路一段50號18樓之2 |
申請商統一編號 | 22854229 |
製造商名稱 | DIASORIN INC. |
製造廠廠址 | 1951 NORTHWESTERN AVE. P. O. BOX 285 STILLWATER, MN U.S.A. |
製造廠公司地址 | (空) |
製造廠國別 | US |
製程 | (空) |
異動日期 | 2018/06/05 |
製造許可登錄編號 | QSD4168 |
許可證字號衛署醫器輸字第016235號 |
註銷狀態已註銷 |
註銷日期2018/05/25 |
註銷理由許可證已逾有效期 |
有效日期2016/03/28 |
發證日期2006/03/28 |
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DHAS0601623505 |
中文品名岱安韶韻環孢靈放射免疫分析試劑組 |
英文品名DiaSorin CYCLO-Trac SP-Whole Blood RIA |
效能利用放射免疫法定量分析人體全血中之環孢靈(Cyclosporin A, Cyclosporine, Sandimmune)。 |
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.1235 環孢靈試驗系統 |
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CYCLO-Trac SP NSB ImmunoSep: Donkey anti-mouse serum/normal mouse serum premix is diluted in phosphate-buffered saline containing 0.08% sodium azide and a surfactant. Blue dye is added.\nCYCLO-Trac SP Calibrators (0-6): Cyclosporine-free serum cotains 0.1% sodium azide and a surfactant. Six cyclosporine calibrators, at nominal concentrations ranging from 0-1200 ng/ml, are prediluted in human serum.\nAnti-CYCLO-Trac SP ImmunoSep: Monoclonal mouse anti-cyclosporine antibody and donkey anti-mouse/normal mouse serum premix is diluted in phosphate-buffered saline containing 0.08% sodium azide and a surfactant.\n125I CYCLO-Trac SP: A derivative of cyclosporine is labeled with iodine-125 and diluted in citrate-EDTA buffer which contains 0.05% sodium azide, human serum and a surfactant. Red dye is added.\nCYCLO-Trac SP Controls (level 1 and level 2): Ranges for each lot are printed on the control vials included with each kit. 0.1% sodium azide and other stabilizers are added.\n |
醫器規格#23000: 200tubes/kit |
限制項目輸 入;;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) |
申請商名稱新科化實業有限公司 |
申請商地址台北市中正區忠孝西路一段50號18樓之2 |
申請商統一編號22854229 |
製造商名稱DIASORIN INC. |
製造廠廠址1951 NORTHWESTERN AVE. P. O. BOX 285 STILLWATER, MN U.S.A. |
製造廠公司地址(空) |
製造廠國別US |
製程(空) |
異動日期2018/06/05 |
製造許可登錄編號QSD4168 |
岱安韶韻環孢靈放射免疫分析試劑組地圖 [ 導航 ]
岱安韶韻環孢靈放射免疫分析試劑組的地址位於
台北市中正區忠孝西路一段50號18樓之2