Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)

This category includes in vitro diagnostic (IVD) kits designed to detect cotinine, a metabolite of nicotine, in clinical specimens such as blood, saliva, or urine. These kits use an enzyme immunoassay (EIA) method to qualitatively or quantitatively measure cotinine levels, which helps assess tobacco use or exposure in clinical and research settings.

Devices in this category are supplied as complete reagent kits containing all necessary components for testing and are regulated as in vitro diagnostic medical devices. They are intended for use by trained laboratory personnel and must comply with applicable IVD regulatory requirements for performance, safety, and labeling in the jurisdictions where they are marketed.