Total IgE Antibody Test Kit (Enzyme-Linked Immunosorbent Assay Method) - NMPA Registration 苏械注准20202401721
Access comprehensive regulatory information for Total IgE Antibody Test Kit (Enzyme-Linked Immunosorbent Assay Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20202401721 and owned by HOB Biotech Group Corp., Ltd.. The device was approved on May 12, 2022.
This page provides complete registration details including registrant information, province location (Jiangsu), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
This product is used to quantitatively detect the content of total IgE antibodies in human serum.
该产品用于定量检测人血清中的总IgE抗体的含量。
Microplate coated with anti-IgE Anti-IgE antibody coated on microplate 1×96 anti-IgE antibody-biotin Anti-IgE antibody-biotin dissolved in buffer 1×16ml horseradish peroxidase-streptavidin conjugate Horseradish peroxidase-streptavidin dissolved in buffer 1×16mL concentrated cleaning solution (25x) Tween dissolved in phosphate buffer 1×50mL substrate solution (TMB) tetramethylbenzidine dissolved in buffer 1×16mL stop solution (0.5MH2SO4). 0.5M H2SO4 1×16mL dilution salt buffer 1×50mL calibrator* (0,0.7,3.5,17.5,50,100 IU/mL) Raw material from high levels of total IgE serum used to plot the standard curve; The calibrators are rated as follows: 0, 0.7, 3.5, 17.5, 50, 100, and the calibrators can be traced back to the WHO (World Health Organization) IgE Reference Material (No. 75/502) 6×1.5mL High Quality Control The raw material comes from a high level of total IgE serum to ensure the effectiveness of the reagent; Target range: 30.1-141.3 IU/ml 1×1.5mL Low quality control The raw material is derived from low levels of total IgE serum, target range: 0-30.0 IU/ml 1×1.5 mL
包被抗IgE的微孔板 抗IgE抗体包被在微孔板上 1×96抗IgE抗体-生物素 抗IgE抗体-生物素溶于缓冲液中 1×16ml辣根过氧化物酶-链霉亲和素结合液 辣根过氧化物酶-链霉亲和素溶于缓冲液中 1×16mL浓缩清洗液(25x) 吐温溶于磷酸盐缓冲液中 1×50mL底物液(TMB) 四甲基联苯胺溶于缓冲液中 1×16mL终止液 (0.5MH2SO4) 0.5M H2SO4 1×16mL稀释液 盐缓冲液 1×50mL校准品* (0，0.7，3.5，17.5，50，100 IU/mL) 原料来自高水平的总IgE血清，用于绘制标准曲线；校准品的定值分别为：0，0.7，3.5，17.5，50，100；校准品均可以溯源至WHO(世界卫生组织) IgE参考物质（编号：75/502） 6×1.5mL高质控 原料来自高水平的总IgE血清，用于确保试剂的有效性;靶值范围：30.1-141.3 IU/ml 1×1.5mL低质控 原料来自低水平的总IgE血清，靶值范围：0-30.0 IU/ml 1×1.5mL
Store at 2~8°C, valid for 15 months. All reagents are stored at 2~8 °C when not in use, and avoid repeatedly opening the package. Unused microporous strips should be put back in a foil bag and sealed with desiccant. Do not use when the kit expires.
2~8℃保存，有效期为15个月。所有试剂不使用时保存在2~8℃，避免反复打开包装。不使用的微孔条应放回锡箔纸袋中封好，并将干燥剂一同放入。试剂盒过期请勿使用。