因諾瓦抗心脂質抗體免疫球蛋白M酵素連結面液分析法檢驗系統
QUANTA LiteTM ACA IgM III

適應症
利用免疫酵素法進行人體血清檢體內之免疫球蛋白M抗心磷脂質抗體之半定量檢測。  
劑型
 
包裝
#708630: 96 tests。 
許可證字號
衛部藥製字第015339號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2025-12-08  
發證日期
2005-12-08  
許可證種類
09 
中文品名
因諾瓦抗心脂質抗體免疫球蛋白M酵素連結面液分析法檢驗系統 
英文品名
QUANTA LiteTM ACA IgM III 
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
DHA00601533904 
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 cardiolipin antigen as well as both bovine and human β2 GPI (12-1 x 8 wells), with holder in foil package containing desiccants \n2. ACA Negative Control, 1 vial of buffer containing preservative and human serum with no human antibodies to cardiolipin, prediluted, 1.2mL \n3. ACA HRP IgM Control, 1 vial of buffer containing preservative and human serum antibodies to cardiolipin, prediluted, 1.2mL \n4. ACA HRP IgM Calibrator A, 1 vial of buffer containing preservative and human serum antibodies to cardiolipin, prediluted, 1.2mL \n5. ACA HRP IgM Calibrator B, 1 vial of buffer containing preservative and human serum antibodies to cardiolipin, prediluted, 1.2mL \n6. ACA HRP IgM Calibrator C, 1 vial of buffer containing preservative and human serum antibodies to cardiolipin, prediluted, 1.2mL \n7. ACA HRP IgM Calibrator D, 1 vial of buffer containing preservative and human serum antibodies to cardiolipin, prediluted, 1.2mL
1 8. ACA HRP IgM Calibrator E, 1 vial of buffer containing preservative and human serum antibodies to cardiolipin, prediluted, 1.2mL \n9. ACA Sample Diluent, 1 vial – containing PBS-buffered saline, protein stabilizers and preservative, 50mL \n\n10. ACA PBS Concentrate, 1 vial of 40x concentrate - colored red containing PBS-buffered saline, 25mL. Refer to the Methods Section for dilution instructions. \n\n11. HRP IgM Conjugate, (goat), anti-human IgM, 1 vial – colored green containing buffer, protein stabilizers and preservative, 10mL \n12. TMB Chromogen, 1 vial containing stabilizers, 10mL \n13. HRP Stop Solution, 0.344M Sulfuric Acid, 1 vial – colorless, 10mL