C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

C-reactive protein (CRP) IVD kits using nephelometry or turbidimetry measure levels of this blood protein to help diagnose infections, inflammation, or cardiovascular risk. These tests are commonly used in clinical labs to assess acute-phase responses and monitor conditions like rheumatoid arthritis or sepsis, with high-sensitivity variants detecting even low CRP levels for early disease detection.

These devices are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 510(k) clearance, depending on the jurisdiction. They are generally supplied as reagent kits for laboratory use, often requiring calibration and maintenance of specialized equipment for accurate results. Classification varies by region, but most fall under higher-risk categories due to their role in critical patient management.