Drug-testing specimen collection kit IVD

A drug-testing specimen collection kit IVD is a single-use device designed to collect, preserve, and/or transport biological samples such as urine, saliva, sweat, or hair for the purpose of drug testing or other in vitro diagnostic investigations. It includes a covered receptacle and associated tools or materials needed for proper specimen handling in both home and clinical environments.

As a single-use in vitro diagnostic device, this category is intended for one-time use only and is regulated based on its role in specimen collection rather than direct diagnosis. Devices in this category are typically supplied as sterile, ready-to-use kits and are subject to regulatory requirements governing IVDs that support diagnostic testing, without claiming therapeutic or diagnostic action themselves.