Anti-Müllerian Hormone Test Kit (Chemiluminescence Immunoassay) - NMPA Registration 湘械注准20252400105
Access comprehensive regulatory information for Anti-Müllerian Hormone Test 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 湘械注准20252400105 and owned by Fosun Diagnostic Technology (Changsha) Co., Ltd. The device was approved on January 22, 2025.
This page provides complete registration details including registrant information, province location (Hunan), 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.
供医疗机构用于体外定量检测人体血清和血浆样本中抗缪勒氏管激素(AMH)含量，临床上用于监测卵巢储备力和多囊卵巢综合征的辅助诊断。
R1：生物素化抗体试剂1， 生物素化的抗缪勒氏管激素抗体 ≥100μg/L；R2：酶结合物试剂2，碱性磷酸酶标记的抗缪勒氏管激素抗体≥50μg/L；R3：磁珠混悬液试剂3， 链霉亲和素标记的磁珠 ≥0.1mg/mL； AMH CAL：抗缪勒氏管激素校准品（可选配，独立包装），抗缪勒氏管激素（重组蛋白）[目标靶值范围：S0：0ng/mL，S1：0.050-0.300ng/mL，S2：17.000-25.000ng/mL具体浓度见定值表]；AMH CON：抗缪勒氏管激素质控品（可选配，独立包装），抗缪勒氏管激素（重组蛋白）[目标靶值范围： C1：0.600-1.400ng/mL，C2：6.000-14.000ng/mL具体浓度见定值表]。
1. 在 2～8°C避光、密封的储存条件下，试剂盒有效期为 12 个月；2. 试剂启用后，置于分析仪“冷藏槽”上可稳定 30 天；3. 校准品、质控品开封后应密封， 在 18～25°C避光的条件下贮存，可稳定 6 小时，2～8°C