抗肝/肾微粒体1型IgG抗体测定试剂盒（化学发光法） - NMPA Registration 粤械注准20252400193
Access comprehensive regulatory information for 抗肝/肾微粒体1型IgG抗体测定试剂盒（化学发光法） 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20252400193 and owned by Shenzhen Yhlo Biotech Co., Ltd.. The device was approved on February 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.
用于体外定量测定人血清和（或）血浆中抗肝/肾微粒体1型IgG抗体（LKM-1 IgG）的含量。临床上主要用于辅助诊断II型自身免疫性肝炎。
主要由试剂1（R1）、试剂2（R2）、试剂3（R3）、试剂4（R4）、校准品1（CAL1）、校准品2（CAL2）、校准品3（CAL3）组成。具体组分详见产品说明书。
Reagents and calibrators are stored vertically unopened at 2~8°C: stable for 18 months. Reagents and calibrators are stored at 2~8°C after first use: stable for 28 days. The reagent is stored at 2~8°C: it can be stable for 28 days. The calibrator can be stored stably for 8 hours at room temperature (20~25°C).
试剂及校准品未开封竖直存放于2～8℃：可稳定18个月。试剂及校准品首次使用后存放于2～8℃：可稳定28天。试剂2～8℃在机存放：可稳定28天。校准品在室温（20～25℃）下，可稳定保存8小时。