適應症
利用免疫酵素法 (Enzyme-Linked Immunoassay, ) 進行人類血清檢體內之過氧化髓酶(myeloperoxidase, MPO) 抗體免疫球蛋白G (IgG)之半定量檢測。  
劑型
 
包裝
708700 96tests 
許可證字號
衛部藥製字第016450號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2026-04-21  
發證日期
2006-04-21  
許可證種類
09 
中文品名
因諾瓦MPO免疫球蛋白G酵素連結免疫分析法試劑組 
英文品名
QUANTA Lite™ MPO IgG ELISA 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
碩景股份有限公司  
申請商地址
台北市信義區松德路74號8樓 
通關簽審文件編號
DHA00601645001 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
INOVA DIANOSTICS, INC. 9900 OLD GROVE ROAD, SAN DIEGO, CA 92131 U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 1. Polystyrene microwell ELISA plate coated with a purified MPO 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 MPO, prediluted, 1.2mL 3. MPO ELISA Low Positive, 1 vial of buffer containing preservative and human serum antibodies to MPO, prediluted, 1.2mL 4. MPO ELISA High Positive, 1 vial of buffer containing preservative and human serum antibodies to MPO, 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 Solut