House dust allergen-specific IgE antibody detection kit (enzyme-linked immunocapture assay) - NMPA Registration 苏械注准20202401743
Access comprehensive regulatory information for House dust allergen-specific IgE antibody detection kit (enzyme-linked immunocapture 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20202401743 and owned by HOB Biotech Group Corp., Ltd.. The device was approved on August 25, 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 house dust allergen-specific IgE antibodies in human serum.
该产品用于定量检测人血清中屋尘过敏原特异性IgE抗体的含量。
IgE-coated microplates, horseradish peroxidase monostreptavidin conjugate, concentrated cleaning solution (25x), substrate solution (TMB), stop solution (0.5MH2S04), house dust allergen biotin. (Please refer to the product manual for details)
包被抗 IgE 的微孔板，辣根过氧化物酶一链霉亲和素结合液，浓缩清洗液 (25x) ，底物液 (TMB)，终止液(0.5MH 2 S0 4 ) ，屋尘过敏原一生物素。(具体内容详见产品说明书)
Store at 2~8°C, valid for 15 months. The production date and expiration date are shown in the label. 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。 生产日期、失效日期见标签。 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。