肺炎衣原体IgG抗体检测试剂盒（磁微粒化学发光法） - NMPA Registration 国械注准20253400193
Access comprehensive regulatory information for 肺炎衣原体IgG抗体检测试剂盒（磁微粒化学发光法） in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253400193 and owned by Shandong Kanghua Biotechnology Co., Ltd.. The device was approved on January 20, 2025.
This page provides complete registration details including registrant information, province location (Shandong), 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.
本产品用于体外定性检测人血清样本或血浆样本中肺炎衣原体IgG抗体。
磁性微球溶液、示踪物结合物、校准品（C1、C2）、质控品（Q1、Q2）、标本稀释液。（具体内容详见产品说明书）
Store at 2~8°C, valid for 18 months.
2~8℃保存，有效期18个月。