Full-scale C-reactive protein (ultra-sensitive CRP + conventional CRP) assay kit (rate scatter turbidimetry) - NMPA Registration 粤械注准20242401073
Access comprehensive regulatory information for Full-scale C-reactive protein (ultra-sensitive CRP + conventional CRP) assay kit (rate scatter turbidimetry) 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20242401073 and owned by Goldsite Diagnostics Inc.. The device was approved on August 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.
It is used for in vitro quantitative determination of C-reactive protein content in human whole blood and serum. Full-scale C-reactive protein is primarily used as a non-specific marker of inflammation and to assess cardiovascular disease risk.
用于体外定量测定人体全血、血清中C反应蛋白的含量。全量程C反应蛋白主要作为一种非特异性炎症指标和用于评价心血管疾病风险。
The kit consists of latex, buffer, and sample diluent, where: Latex: 0.05%-0.25% rabbit anti-C-reactive protein antibody-coated latex particles; Buffer: phosphate buffer solution containing 0.05% preservative (0.5‰PC300); Sample diluent: buffer solution containing 0.01%-0.02% surfactant;
试剂盒由乳胶、缓冲液、样本稀释液组成，其中： 乳胶：0.05%-0.25%兔抗C反应蛋白抗体包被的乳胶颗粒； 缓冲液：含0.05%防腐剂（0.5‰PC300）的磷酸盐缓冲溶液； 样本稀释液：含0.01%-0.02%表面活性剂的缓冲溶液；
Store at 2-8°C, expiration date of 365 days; After opening, the latex can be stored at 2-8 °C for 30 days, and the GPP-100 test card can be stored at room temperature (10-30 °C) for 4 hours and 2-8 °C for 30 days after opening.
2-8℃保存，有效期为365天； 开启后乳胶在机2-8℃保存30天，GPP-100测试卡开袋后室温（10-30℃）可保存4小时、2-8℃保存30天。