Mycoplasma pneumoniae IgM antibody detection test kit (magnetic microparticle chemiluminescence method)
- Device class
- Class III
- Model specifications
- 25 servings/box, 50 servings/box, 100 servings/box, 200 servings/box.25人份/盒、50人份/盒、100人份/盒、200人份/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253400108
- Approval date
- January 10, 2025
- Expiry date
- January 09, 2030
- Name
- Shandong Kanghua Biotechnology Co., Ltd.山东康华生物医疗科技股份有限公司
- Province/Region
- Shandong山东
- Address
- No. 699, Yuehe Road, Weifang Economic Development Zone潍坊经济开发区月河路699号
- Production address
- 潍坊经济开发区古亭街8877号
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IgM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。（具体内容详见说明书）
Store at 2~8°C, valid for 18 months.
2~8℃保存，有效期18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Mycoplasma pneumoniae IgM antibody detection test kit (magnetic microparticle chemiluminescence method) 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20253400108 and owned by Shandong Kanghua Biotechnology Co., Ltd.. The device was approved on January 10, 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.