INTENDED USE

This product is a C-Reactive Protein (CRP) fluorescent immunochromatographic assay UNCUT SHEET (semi-finished product). It is NOT a final finished reagent and CANNOT be used directly for clinical sample testing.

This UNCUT SHEET must undergo subsequent processing steps, including cutting and card assembly, to be manufactured into CRP test cards (finished reagent kit). Only after such processing may it be used in conjunction with a compatible fluorescence immunoassay analyzer for the in vitro quantitative detection of C-Reactive Protein (CRP) in human serum, plasma, or whole blood samples. Clinically, it is primarily intended for the auxiliary diagnosis and monitoring of inflammatory conditions, including the auxiliary diagnosis of acute bacterial infection and inflammatory diseases, the differential diagnosis between bacterial and viral infections, the assessment of infection severity, and the monitoring of treatment efficacy and disease progression.

This UNCUT SHEET is intended solely for internal use by the manufacturer. It shall not be registered, sold, or used clinically as an independent medical device, and shall not be used directly for human sample testing.