岱安韶韻環孢靈放射免疫分析試劑組

醫療器材許可證 · 許可證字號：衛署醫器輸字第016235號

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

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)。

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

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): …展開

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收合

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.

製造廠國別

US

異動日期

2018/06/05

製造許可登錄編號

QSD4168

建立時間 2026-09-22 15:59:35 · 更新時間 2026-09-22 15:59:35