INTENDED USE

This product is a Procalcitonin (PCT) 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 PCT 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 Procalcitonin (PCT) in human serum, plasma, or whole blood samples. Clinically, it is primarily intended for the auxiliary diagnosis of bacterial infectious diseases, including the differential diagnosis between bacterial and viral infections, early diagnosis of systemic severe bacterial infections and sepsis, assessment of infection severity, and therapeutic monitoring.

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.