因諾瓦PR-3免疫球蛋白G酵素連結免疫分析法試劑組

醫療器材許可證 · 許可證字號：衛署醫器輸字第016451號

許可證字號

衛署醫器輸字第016451號

有效日期

2031/04/21

發證日期

2006/04/21

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHA00601645103

中文品名

因諾瓦PR-3免疫球蛋白G酵素連結免疫分析法試劑組

英文品名

QUANTA Lite™ PR-3 IgG ELISA

效能

利用免疫酵素法 (Enzyme-Linked Immunoassay, ) 進行人類血清檢體內之絲氨酸蛋白酶3(serine protease 3, PR-3) 抗體免疫球蛋白G (IgG)之半定量檢測。

醫器主類別一

C 免疫學及微生物學

醫器次類別一

C.5660 多發性自體抗體免疫試驗系統

主成分略述

1. Polystyrene microwell ELISA plate coated with a purified PR-3 antigen, (12-1 x 8 wells), with holder in foil package containing desiccants 2. ELISA Negative Control, 1 vial of buffer containing preservative and human …展開

1. Polystyrene microwell ELISA plate coated with a purified PR-3 antigen, (12-1 x 8 wells), with holder in foil package containing desiccants 2. ELISA Negative Control, 1 vial of buffer containing preservative and human serum with no human antibodies to PR-3, prediluted, 1.2mL 3. PR-3 ELISA Low Positive, 1 vial of buffer containing preservative and human serum antibodies to PR-3, prediluted, 1.2mL 4. PR-3 ELISA High Positive, 1 vial of buffer containing preservative and human serum antibodies to PR-3, prediluted, 1.2mL 5. HRP Sample Diluent, 1 vial – colored pink containing Tris-buffered saline, Tween 20, protein stabilizers and preservative, 50mL 6. HRP Wash Concentrate, 1 vial of 40x concentrate - colored red containing Tris-buffered saline and Tween 20, 25mL. Refer to the Methods Section for dilution instructions. 7. HRP IgG Conjugate, (goat), anti-human IgG, 1 vial – colored blue containing buffer, protein stabilizers and preservative, 10mL 8. TMB Chromogen, 1 vial containing stabilizers, 10mL 9. HRP Stop收合

醫器規格

708705 96 tests

限制項目

輸 入

申請商名稱

碩景股份有限公司

申請商地址

臺北市信義區松德路74號8樓

申請商統一編號

80672330

製造商名稱

INOVA DIANOSTICS, INC.

製造廠廠址

9900 OLD GROVE ROAD, SAN DIEGO, CA 92131 U.S.A.

製造廠國別

US

異動日期

2026/03/17

製造許可登錄編號

QSD14865

建立時間 2026-09-22 15:59:33 · 更新時間 2026-09-22 15:59:33