適應症
利用酵素免疫法進行人類血清檢體內之Chromatin自體抗體之半定量檢測。  
劑型
 
包裝
708710 (96 determinations) 
許可證字號
衛部藥製字第020336號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2029-06-17  
發證日期
2009-06-17  
許可證種類
09 
中文品名
因諾瓦 Chromatin 染色質酵素連結免疫分析法檢驗系統 
英文品名
INOVA QUANTA Lite TM Chromatin 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
DHA00602033605 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD, SAN DIEGO, CA 92131 USA 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 Chromatin antigen (12-1 x 8 wells), with holder in foil package containing desiccants.
1 2.ELISA Negative Control, 1 vial of buffer containing preservative and human serum with no human antibodies to Chromatin, prediluted, 1.2mL.
1 3.Chromatin ELISA Low Positive, 1 vial of buffer containing preservative and human serum antibodies to Chromatin, prediluted, 1.2mL.
1 4.Chromatin ELISA High Positive, 1 vial of buffer containing preservative and human serum antibodies to Chromatin, prediluted, 1.2mL.
1 5.HRP Sample Diluent, 1 vial – colored pink containing Tris-buffered saline, Tween 20, protein stabilizers and preservative, 50mL.
1 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.
1 7.HRP IgG Conjugate, (goat), anti-human IgG, 1 vial – colored blue containing buffer, protein stabilizers and preservative, 10mL.
1 8.TMB Chromogen, 1 vial containing stabilizers, 10mL
1 9.HRP Stop Solution, 0.334M Sulfuric Acid, 1 vial – colorless, 10mL.