Anti-C1q antibody IgG control - NMPA Registration 粤械注准20242401355
Access comprehensive regulatory information for Anti-C1q antibody IgG control 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20242401355 and owned by Zhuhai Livzon Diagnostics INC.. The device was approved on October 14, 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.
This product is used for the quality control of the anti-C1q antibody IgG assay kit (chemiluminescence method) produced by our company.
本产品用于本公司生产的抗C1q抗体IgG测定试剂盒（化学发光法）的质量控制。
Controls consist of low-value controls, high-value controls, and complex solutions. The low-value control and high-value control were lyophilized with different concentrations of anti-C1q humanized antibody (recombinant) and stored in phosphate buffer with casein as stabilizer; The complex solution is an aqueous solution containing the preservative Proclin 300.
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、高值质控品为冻干品，含不同浓度抗C1q人源化抗体（重组），储存于添加了酪蛋白为稳定剂的磷酸盐缓冲液中；复溶液为含防腐剂Proclin 300的水溶液。
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.
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。