岱安韶韻三碘甲狀腺素125I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016261號

許可證字號

衛署醫器輸字第016261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

2016/03/29

發證日期

2006/03/29

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHAS0601626106

中文品名

岱安韶韻三碘甲狀腺素125I放射免疫分析試劑組

英文品名

DiaSorin Clinical Assays GammaCoat T3 125I RIA Kit

效能

GammaCoat甲狀腺素[125I]三碘甲狀腺素放射免疫分析是用來定量分析血清和血漿中三碘甲狀腺素濃度的量。

醫器主類別一

A 臨床化學及臨床毒理學

醫器次類別一

A.1710 總三碘甲狀腺素試驗系統

主成分略述

1. [125I] Triiodothyronine Tracer Cat. No. CA-2684 1/5 per/kit: each vial contains approximately 7 μCi of tracer (<1 μg/ml T3) in 6 ml of phosphate buffered saline and ANS (8-anilino-1-napthalene sulfonic acid) with 0.1%…展開

1. [125I] Triiodothyronine Tracer Cat. No. CA-2684 1/5 per/kit: each vial contains approximately 7 μCi of tracer (<1 μg/ml T3) in 6 ml of phosphate buffered saline and ANS (8-anilino-1-napthalene sulfonic acid) with 0.1% sodium azide as a preservative.\n2. Rabbit Anti-Triiodothyronine Serum Coated Tubes Cat. No. CA-2175 100/500 per kit 12 x 75 mm tubes are coated with rabbit anti-Triiodothyronine serum (titer <1 μg/tube) and packaged in a plastic bag.\n3. T3 RIA Assay Buffer Cat. No. CA-2781 1/5 per/kit: each bottle contains 120 ml of phosphate buffered saline with 0.1% sodium azide as a preservative.\n4. T3 RIA Control Sera, Level I & II Cat. No. CA-2444, CA-2445 2/2 per/kit: each vial contains 1.5 ml of L-3, 3’, 5-triiodothyronine in processed human serum with 0.1% sodium azide as a preservative.\n5. T3 RIA Serum Blank Cat. No. CA-2920 1/1 per/kit: each vial contains 1.5 ml of processed human serum with 0.1% sodium azide as a preservative.\n6. T3 RIA Serum Standards Cat. No. CA-2921, CA-2925 5/5 per/kit: e收合

醫器規格

#CA-1541: 100 tests/kit#CA-1561: 500 tests/kit

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