Mycoplasma pneumoniae IgG Antibody Test Kit (chemiluminescence)
- Device class
- Class III
- Model specifications
- 50 tests/box, 2×50 tests/box.50测试/盒、2×50测试/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243401729
- Approval date
- September 12, 2024
- Expiry date
- September 11, 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
This product is used for the in vitro qualitative detection of Mycoplasma pneumoniae IgG antibody in human serum or plasma.
本产品用于体外定性检测人血清或血浆中的肺炎支原体IgG 抗体。
This product consists of a master reagent (including magnetic beads and enzyme markers) and a calibrator (including a negative calibrator, a positive calibrator, and a complex solution). (Please refer to the product manual for details)
本产品由主试剂（包括磁珠和酶标记物）和校准品（包括阴性校准品、阳性校准品和复溶液）组成。（具体内容详见产品说明书）
Store at 2~8 °C, valid for 12 months.
2～8 ℃保存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Mycoplasma pneumoniae IgG Antibody Test Kit (chemiluminescence) 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20243401729 and owned by Zhuhai Livzon Diagnostics INC.. The device was approved on September 12, 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.