Chlamydia Pneumoniae IgG Antibody Test Kit (Colloidal Gold Method)
- Device class
- Class III
- Model specifications
- 1人份/袋,20人份/盒,40人份/盒.1人份/袋，20人份/盒，40人份/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243402654
- Approval date
- December 30, 2024
- Expiry date
- December 29, 2029
- Name
- Zhuhai Livzon Diagnostics INC.珠海丽珠试剂股份有限公司
- Province/Region
- Guangdong广东
- Address
- Building 1, No. 266, Tongchang Road, Xiangzhou District, Zhuhai珠海市香洲区同昌路266号1栋
- Production address
- 珠海市香洲区同昌路266号
本产品用于体外定性检测人血清、血浆或全血样本中的肺炎衣原体IgG抗体.
本产品用于体外定性检测人血清、血浆或全血样本中的肺炎衣原体IgG抗体。
检测卡、吸管、样本稀释液.(具体内容详见产品说明书)
检测卡、吸管、样本稀释液。（具体内容详见产品说明书）
2～30℃避光干燥保存,有效期12个月.
2～30℃避光干燥保存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Chlamydia Pneumoniae IgG Antibody Test Kit (Colloidal Gold 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20243402654 and owned by Zhuhai Livzon Diagnostics INC.. The device was approved on December 30, 2024.
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.