Anti-C1q antibody IgG assay kit (chemiluminescence method) - NMPA Registration 粤械注准20242401360
Access comprehensive regulatory information for Anti-C1q antibody IgG assay kit (chemiluminescence method) 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20242401360 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 suitable for the quantitative detection of anti-C1q antibody IgG content in human serum in vitro, and is mainly used for the diagnosis and monitoring of lupus nephritis, and the diagnosis of hypocomplementaemic urticarial vasculitis (HUVS), membranoproliferative glomerulonephritis (MPGN) and Felty syndrome.
本产品适用于体外定量检测人血清中抗C1q抗体IgG的含量，临床上主要用于狼疮肾炎的诊断和监测，低补体血症性荨麻疹性血管炎（HUVS）、膜增生性肾小球肾炎（MPGN）和Felty综合征的诊断。
This product consists of a master reagent and a calibrator. Among them, the main reagents include magnetic beads (R1) (magnetic beads coated with CLR) and enzyme marker (R2) (murine anti-human IgG monoclonal antibody with alkaline phosphatase), and calibrators include calibrator 1 (lyophilized antibodies containing anti-C1q humanized antibodies), calibrator 2 (lyophilized antibodies containing anti-C1q humanized antibodies), and complex solution (aqueous solution (containing Proclin 300).
本产品由主试剂和校准品组成。其中，主试剂包括磁珠（R1）（包被CLR的磁珠）和酶标记物（R2）（含碱性磷酸酶标记的鼠抗人IgG单克隆抗体），校准品包括校准品1（含抗C1q人源化抗体冻干品）、校准品2（含抗C1q人源化抗体冻干品）和复溶液（水溶液（含Proclin 300）。
1. Store unopened at 2~8 °C, valid for 12 months. After opening, the reagent should be stored at 2~8 °C or in the machine (2~8 °C), and the validity period is 30 days. 2. Keep the beads upright so that the beads are easy to resuspend. 3. After the calibrator is reconstituted, it can be stored sealed at room temperature (18~28°C) for 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.未开封存放于2~8 ℃，有效期12个月。试剂开封后存放于2~8 ℃或在机（2～8 ℃）存放，有效期30天。2.保持竖直向上，以便磁珠容易重新悬浮。3.校准品复溶后，室温（18~28℃）密封储存，可保存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。