Total testosterone IVD, kit, enzyme immunoassay (EIA)

This category includes test kits designed to measure the total amount of testosterone in a patient's blood, saliva, or other clinical sample. These kits use an enzyme immunoassay method to detect testosterone levels, which helps healthcare providers assess hormonal function related to reproduction, development, or endocrine disorders.

Devices in this category are in vitro diagnostic (IVD) products supplied as complete reagent kits for use in laboratory settings. They are regulated based on their intended use and risk profile, with classification depending on the jurisdiction, and are intended for professional use by trained laboratory personnel.