C-peptide IVD, kit, chemiluminescent immunoassay

This category includes in vitro diagnostic kits designed to measure C-peptide levels in clinical specimens such as blood or serum. These kits use a chemiluminescent immunoassay method to detect C-peptide, which is a biomarker used to assess endogenous insulin production and help differentiate between type 1 and type 2 diabetes, evaluate insulin therapy, and investigate hypoglycemia.

Devices in this category are regulated as in vitro diagnostic medical devices and are supplied as complete kits containing all necessary reagents and materials for performing the assay. They are intended for use in clinical laboratories by trained professionals and are not intended for point-of-care or self-testing use unless specifically indicated by the manufacturer’s instructions for use.