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China NMPA legacy archive 粤械注准20242401073

Full-scale C-reactive protein (ultra-sensitive CRP + conventional CRP) assay kit (rate scatter turbidimetry)

全量程C反应蛋白(超敏CRP+常规CRP)测定试剂盒(速率散射比浊法)
Goldsite Diagnostics Inc.Class IINMPAApproved August 12, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
20 servings/box, 100 servings/box, 200 people/box, 400 servings/box
20人份/盒、100人份/盒、200人份/盒、400人份/盒
Approval department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration information
Registration number
粤械注准20242401073
Approval date
August 12, 2024
Expiry date
August 11, 2029
Registrant
Name
Goldsite Diagnostics Inc.
深圳市国赛生物技术有限公司
Province/Region
Guangdong
广东
Address
Building 1001, Guosai Science and Technology Building, No. 9 Rongtian Road, Jinsha Community, Kengzi Street, Pingshan District, Shenzhen
深圳市坪山区坑梓街道金沙社区荣田路9号国赛科技大厦1号楼1001
Production facility
Production address
深圳市坪山区坑梓街道丹碧路与荣田路交汇处西南角深圳市国赛生物技术有限公司生产与研发厂区
Intended use
English

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.

中文

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。

Structure and composition
English

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;

中文

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;

Storage conditions and expiration
English

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.

中文

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。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for Full-scale C-reactive protein (ultra-sensitive CRP + conventional CRP) assay kit (rate scatter turbidimetry), registration 粤械注准20242401073. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.