Insulin IVD, kit, enzyme immunoassay (EIA)

This category includes diagnostic test kits designed to measure the amount of insulin in a patient's blood or other clinical sample. These kits use an enzyme immunoassay (EIA) method to provide quantitative results, helping healthcare providers assess insulin levels for diagnosing and managing conditions such as diabetes, insulin resistance, or hypoglycemia.

Devices in this category are in vitro diagnostic (IVD) medical devices supplied as kits containing reagents and necessary components for performing the test. They are intended for use in clinical laboratories by trained professionals and are regulated based on their intended use and risk profile, with individual devices subject to conformity assessment under applicable IVD regulations.