Pure Global

抗突变型瓜氨酸化波形蛋白抗体IgG质控品 - NMPA Registration 粤械注准20242401383

Access comprehensive regulatory information for 抗突变型瓜氨酸化波形蛋白抗体IgG质控品 in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242401383 and owned by Zhuhai Livzon Diagnostics INC.. The device was approved on October 16, 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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class II
粤械注准20242401383
抗突变型瓜氨酸化波形蛋白抗体IgG质控品
NMPA Registration Number: 粤械注准20242401383
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

本产品配合本公司生产的抗突变型瓜氨酸化波形蛋白抗体IgG测定试剂盒(化学发光法)使用,用于抗突变型瓜氨酸化波形蛋白抗体IgG项目检测时的质量控制.

中文

本产品配合本公司生产的抗突变型瓜氨酸化波形蛋白抗体IgG测定试剂盒(化学发光法)使用,用于抗突变型瓜氨酸化波形蛋白抗体IgG项目检测时的质量控制。

Device Classification
Device Class
Class II
Model Specifications
低值:1 × 1mL;高值:1 × 1mL.
低值:1 × 1mL;高值:1 × 1mL。
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242401383
Approval Date
October 16, 2024
Expiry Date
October 15, 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

质控品由低值质控品、高值质控品和复溶液组成.低值质控品、高值质控品为含有不同浓度的抗MCV抗体(重组)的蛋白稳定剂基质冻干品,复溶液为含防腐剂的水溶液.

中文

质控品由低值质控品、高值质控品和复溶液组成。低值质控品、高值质控品为含有不同浓度的抗MCV抗体(重组)的蛋白稳定剂基质冻干品,复溶液为含防腐剂的水溶液。

Storage Conditions and Expiration
English

Store at 1.2~8 °C, valid for 12 months. 2. After reconstitution, store it tightly at room temperature (18~28 °C), and the validity period is 8 hours; Sealed storage at 2~8°C, valid for 3 days; Sealed storage at -20°C, valid for 30 days, repeated freeze-thaw after remelting should not exceed 3 times, please fully thaw and mix before use.

中文

1.2~8 ℃保存,有效期12个月。 2.复溶后,室温(18~28℃)密封储存,有效期为8个小时;2~8℃密封储存,有效期为3天;-20℃密封储存,有效期为30天,复融后反复冻融不宜超过3次,使用前请充分融化并混匀。

Additional Information
Appendix
产品技术要求、说明书