Artemisia Allergen Specific IgE Antibody Detection Test Kit (Enzyme-linked Immunosorbent Assay) - NMPA Registration 苏械注准20202401668
Access comprehensive regulatory information for Artemisia Allergen Specific IgE Antibody Detection Test Kit (Enzyme-linked Immunosorbent Assay) 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20202401668 and owned by HOB Biotech Group Corp., Ltd.. The device was approved on August 22, 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.
It is used to quantitatively detect the content of mugwort allergen-specific IgE antibodies in human serum.
用于定量检测人血清中艾蒿过敏原特异性IgE抗体的含量。
Anti-IgE-coated microplate: 1.5~3.0 μg/mL anti-IgE antibody coated on microplate, specification: 1×96 Horseradish peroxidase-streptavidin conjugate: 1:4000~1:20000 horseradish peroxidase-streptavidin dissolved in 0.05M trimethylolaminomethane buffer, pH 7.2±0.3, specification: 1×16mL Concentrated cleaning solution (25x): 10‰w/v Tween dissolved in 0.03M phosphate buffer, pH 7.2±0.3, Specification: 1×50mL Substrate solution (TMB): tetramethylbenzidine dissolved in buffer, pH 3.55±0.2, Specification: 1×16mL Stop solution (0.5MH2SO4): 0.5M H2SO4, Specification: 1×16mL Artemisia allergen-biotin: Artemisia allergen-biotin dissolved in 0.05M trimethylolaminomethane buffer, pH 7.2±0.3, specification: 4×2.8mL Biogenic: allergens are naturally extracted.
包被抗IgE的微孔板：1.5~3.0 μg/mL抗IgE抗体包被在微孔板上，规格：1×96 辣根过氧化物酶-链霉亲和素结合液：1:4000~1:20000辣根过氧化物酶-链霉亲和素溶于0.05M三羟甲基氨基甲烷缓冲液中，pH7.2±0.3，规格：1×16mL 浓缩清洗液(25x)：10‰w/v吐温溶于0.03M磷酸盐缓冲液中，pH7.2±0.3，规格：1×50mL 底物液(TMB)：四甲基联苯胺溶于缓冲液中，pH3.55±0.2 ，规格：1×16mL 终止液 (0.5MH2SO4)：0.5M H2SO4，规格：1×16mL 艾蒿过敏原-生物素：艾蒿过敏原-生物素溶于0.05M三羟甲基氨基甲烷缓冲液中，pH7.2±0.3，规格：4×2.8mL 生物源性：过敏原均为天然提取。
Store at 2~8°C, valid for 15 months. The production date and expiration date are shown in the label. After opening, it is valid for 28 days under storage conditions at 2-8 °C. Store all reagents at 2-8 °C when not in use, avoiding repeated unpacking. 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。 生产日期、失效日期见标签。 开封后于2-8℃贮存条件下有效期为28天。 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。