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Chlamydia Pneumoniae IgG Antibody Test Kit (Colloidal Gold Method) - NMPA Registration 国械注准20243402654

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.

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NMPA Official Data
Class III
国械注准20243402654
Chlamydia Pneumoniae IgG Antibody Test Kit (Colloidal Gold Method)
肺炎衣原体IgG抗体检测试剂盒(胶体金法)
NMPA Registration Number: 国械注准20243402654
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Intended Use
English

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.

中文

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。

Device Classification
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 Information
Registration Number
国械注准20243402654
Approval Date
December 30, 2024
Expiry Date
December 29, 2029
Registrant
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 Facility
Production Address
珠海市香洲区同昌路266号
Structure and Composition
English

检测卡、吸管、样本稀释液.(具体内容详见产品说明书)

中文

检测卡、吸管、样本稀释液。(具体内容详见产品说明书)

Storage Conditions and Expiration
English

2~30℃避光干燥保存,有效期12个月.

中文

2~30℃避光干燥保存,有效期12个月。

Additional Information
Appendix
产品技术要求、说明书