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Full Range C-reactive Protein (Ultra-sensitive CRP+Conventional CRP) Detection Kit (Immunoturbidimetric Method) - NMPA Registration 粤械注准20222401915

Access comprehensive regulatory information for Full Range C-reactive Protein (Ultra-sensitive CRP+Conventional CRP) Detection Kit (Immunoturbidimetric 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20222401915 and owned by Shenzhen Lifotronic Technology Co., Ltd.. The device was approved on December 05, 2022.

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.

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NMPA Official Data
Class II
粤械注准20222401915
Full Range C-reactive Protein (Ultra-sensitive CRP+Conventional CRP) Detection Kit (Immunoturbidimetric Method)
全量程C反应蛋白(超敏CRP+常规CRP)测定试剂盒(免疫散射比浊法)
NMPA Registration Number: 粤械注准20222401915
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Intended Use
English

It is used for the quantitative determination of C-reactive protein content in human whole blood, serum and plasma samples in vitro, mainly as a non-specific inflammatory index and for evaluating the risk of cardiovascular disease.

中文

用于体外定量测定人全血、血清、血浆样本中C反应蛋白的含量,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。

Device Classification
Device Class
Class II
Model Specifications
Specification 1: 100 test/box, R1: 1×1.8L; R2:1×12mL; Specification 2: 200 test/box, R1: 1×3.6L; R2:1×24mL; Specification 3: 250 test/box, R1: 1×4.5L; R2:1×30mL; Specification 4: 505 test/box, R1: 2×4.5L; R2:1×60.6mL; Specification 5: 350 test/box, R1: 1×6.3L; R2:1×21mL; Specification 6: 400 test/box, R1: 1×7.2L; R2:1×24mL; Specification 7: 505 test/box, R1: 2×4.5L; R2:1×30.3mL; Specification 8: 700 test/box, R1: 2×6.3L; R2:1×42mL; Specification 9: 800 test/box, R1: 2×7.2L; R2:1×48mL; Size 10:400 test/box, R1:1×120mL; R2:1×16mL; Size 11: 600 test/box, R1: 1× 180mL; R2:1×24mL; Size 12: 800 test/box, R1: 1×240mL; R2:1×32mL; Size 13: 1200 test/box, R1: 2× 180mL; R2:2×24mL; Size 14: 1600 test/box, R1: 2×240mL; R2:2×32mL.
规格1:100测试/盒,R1:1×1.8L;R2:1×12mL;规格2:200测试/盒,R1:1×3.6L;R2:1×24mL;规格3:250测试/盒,R1:1×4.5L;R2:1×30mL;规格4:505测试/盒,R1:2×4.5L;R2:1×60.6mL;规格5:350测试/盒,R1:1×6.3L;R2:1×21mL;规格6:400测试/盒,R1:1×7.2L;R2:1×24mL;规格7:505测试/盒,R1:2×4.5L;R2:1×30.3mL;规格8:700测试/盒,R1:2×6.3L;R2:1×42mL;规格9:800测试/盒,R1:2×7.2L;R2:1×48mL;规格10:400测试/盒,R1:1×120mL;R2:1×16mL;规格11:600测试/盒,R1:1×180mL;R2:1×24mL;规格12:800测试/盒,R1:1×240mL;R2:1×32mL;规格13:1200测试/盒,R1:2×180mL;R2:2×24mL;规格14:1600测试/盒,R1:2×240mL;R2:2×32mL。
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20222401915
Approval Date
December 05, 2022
Expiry Date
December 04, 2027
Registrant
Name
Shenzhen Lifotronic Technology Co., Ltd.
深圳普门科技股份有限公司
Province/Region
Guangdong
广东
Address
1st floor, Jindi Tianyue Bay, No. 8 Qizhi East Road, Guancheng Community, Guanhu Street, Longhua District, Shenzhen (intersection of Meiguan Expressway and Huanguan South Road).
深圳市龙华区观湖街道观城社区求知东路8号金地天悦湾(梅观高速与环观南路交汇处)1层
Production Facility
Production Address
广东省东莞市松山湖园区彰化路2号1号厂房4-9楼、11楼
Structure and Composition
English

R1: Citrate buffer, ProClin300; R2: CRP antibody conjugated latex beads.

中文

R1:柠檬酸盐缓冲液 、ProClin300; R2:CRP抗体偶联乳胶微球。

Storage Conditions and Expiration
English

2027-12-04

Additional Information
Appendix
产品标准,产品说明书。