宙斯甲狀腺過氧化(酉每)IgG酵素連結免疫吸收分析檢測系統
Thyroid Peroxidase (TPO) IgG ELISA test system

適應症
用來定性及半定量人類血清中的甲狀腺過氧化(酉每)(thyroid peroxidase, TPO)對應之IgG抗體。  
劑型
 
包裝
# 2Z5051G 
許可證字號
衛部藥製字第018718號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2028-01-08  
發證日期
2008-01-08  
許可證種類
09 
中文品名
宙斯甲狀腺過氧化(酉每)IgG酵素連結免疫吸收分析檢測系統 
英文品名
Thyroid Peroxidase (TPO) IgG ELISA test system 
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
DHA00601871801 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876, USA US
成份表
處方標示 成分名稱 含量 單位
1 1.Plate. 96 wells configured in twelve 1x8-well strips coated with purified human thyroid peroxidase (>= 98% pure). The strips are packaged in a strip holder and sealed in an envelope with desiccant.\n2.Conjugate. Conjugated (horseradish peroxidase) goat anti-human IgG (γchain specific). Ready to use. One, 15 mL vial with a white cap. Preservative added.\n3.Positive Control (Human Serum). One 0.35 mL vial with a red cap. Preservative added.\n4.Calibrator A (Human Serum). One 0.35 mL vial with a white cap. Preservative added.
1 5.Calibrator B (Human Serum). One 0.35 mL vial with a yellow cap. Preservative added.\n6.Calibrator C (Human Serum). One 0.35 mL vial with a orange cap. Preservative added.\n7.Calibrator D (Human Serum). One 0.35 mL vial with a blue cap. Preservative added.\n8.Negative Control (Human Serum). One 0.35 mL vial with a green cap. Preservative added.
1 9.Sample diluent. One 30 mL bottle (green cap) containing Tween-20, bovine serum albumin and phosphate-buffered-saline, (pH 7.2 ± 0.2). Green solution, ready to use. Preservative added. \n10.TMB: One 15 mL amber bottle (amber cap) containing 3,3’ ,5,5’ –tetramethylbenzidine (TMB). Ready to use. Contains DMSO < 15% (w).\n11.Stop solution: One 15 mL bottle (red cap) containing 1M H2SO4, 0.7M HCl. Ready to use.\n12.Wash buffer concentrate (10X): dilute 1 part concentrate + 9 parts deionized or distilled water. One 100 mL bottle (clear cap) containing a 10X concentrated phosphate-buffered-saline and Tween-20 solution (blue solution). Contains preservative NOTE: 1X solution will have a pH of 7.2 ± 0.2.