Estradiol determination reagent kit (chemiluminescence immunoassay) - NMPA Registration 粤械注准20252400019
Access comprehensive regulatory information for Estradiol determination reagent kit (chemiluminescence immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20252400019 and owned by Guangzhou Wondfo BIOTECH Co., Ltd.. The device was approved on January 06, 2025.
This page provides complete registration details including registrant information, province location (Guangdong), 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.
用于体外定量测定血清和血浆样本中的雌二醇的含量。临床上主要用于卵巢疾病的辅助诊断。
试剂盒主要由磁珠包被物(R1)、酶标记物(R2)、样本处理液（R3）、校准品和质控品（选配）组成。其中磁珠包被物(R1)包含包被着雌二醇抗原的磁性微粒；Tris 缓冲液； ProClin 300。酶标记物(R2)包含羊抗兔IgG的碱性磷酸酶标记物；Mes 缓冲液；ProClin 300。样本处理液（R3）包含兔抗雌二醇抗体Tris 缓冲液；ProClin 300。校准品包含不同浓度的雌二醇纯品抗原，冻干粉。质控品（选配）包含不同浓度的雌二醇纯品抗原，冻干粉。
试剂盒：2～8℃保存，未开封有效期18个月，开封2～8℃稳定性为28天。禁止冷冻。校准品和质控品：2～8℃避光保存，未开封有效期18个月；开封复溶后，在室温（18～25℃）环境下可稳定8小时；在-20℃±5℃贮存环境下有效期为30天，冻融次数不超过1次。