岱安韶韻抗利尿激素RIA分析試劑

醫療器材許可證 · 許可證字號：衛署醫器輸字第016460號

許可證字號

衛署醫器輸字第016460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

2016/04/24

發證日期

2006/04/24

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHAS0601646002

中文品名

岱安韶韻抗利尿激素RIA分析試劑

英文品名

DiaSorin VASOPRESSIN RIA

效能

利用放射免疫測定法定量分析人類血漿或其他樣品中的精氨酸抗利尿激素。

醫器主類別一

A 臨床化學及臨床毒理學

醫器次類別一

A.1665 鈉試驗系統

主成分略述

4.1 Vasopressin 1% BSA-borate Buffer: 1% BSA-borate buffer contains thimerosal as a preservative.\n4.2 Arginine Vasopressin Calibrator: purified arginine vasopressin, at a nominal concentration of 80 pg/ml, is made in BS…展開

4.1 Vasopressin 1% BSA-borate Buffer: 1% BSA-borate buffer contains thimerosal as a preservative.\n4.2 Arginine Vasopressin Calibrator: purified arginine vasopressin, at a nominal concentration of 80 pg/ml, is made in BSA-borate buffer containing thimerosal.\n4.3 Vasopressin Antiserum: guinea pig anti-vasopressin serum is diluted in BSA-borate buffer containing thimerosal.\n4.4 125I Vasopressin: (Lys8) vasopressin is labeled with iodine-125 and diluted in BSA-borate-EDTA buffer containing thimerosal.\n4.5 Precipitating Complex (GAGP-PPT): normal guinea pig serum, pre-precipitated with goat anti-guinea pig serum and polyethylene glycol (PEG), is diluted in BSA-borate buffer with preservatives added.\n4.6 Vasopressin Control Plasma: human plasma is spiked, if necessary, with the appropriate amount of arginine vasopressin to obtain a concentration within a specified range. Sodium azide is added as a preservative.\n4.7 ODS-Silica: octadecasilyl-silica is enclosed in plastic columns (Sep-Paks).\n收合

醫器規格

#23065: 65 tests/kit，以下空白。

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 15:59:33 · 更新時間 2026-09-22 15:59:33