In vitro diagnostic (IVD) device

FDA regulates IVDs as devices, with specific labeling rules in 21 CFR 809.10. Many laboratory tests are also subject to CLIA, which is a separate framework.

A diagnostic device that is intended for use in the collection, preparation and examination of specimens taken from the human body.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary