Full Range C-reactive Protein (Ultra-sensitive CRP+Conventional CRP) Detection Kit (Immunoturbidimetric Method)
- 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 number
- 粤械注准20222401915
- Approval date
- December 05, 2022
- Expiry date
- December 04, 2027
- 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 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
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.
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。
R1: Citrate buffer, ProClin300; R2: CRP antibody conjugated latex beads.
R1：柠檬酸盐缓冲液 、ProClin300； R2：CRP抗体偶联乳胶微球。
2027-12-04
- Appendix
- 产品标准，产品说明书。
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.
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