China NMPA legacy archive 粤械注准20222401915Full 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.
- Approval department
- Guangdong Provincial Drug Administration
- Registration number
- 粤械注准20222401915
- Approval date
- December 05, 2022
- Expiry date
- December 04, 2027
- Province/Region
- Guangdong
- 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).
- 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。
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