Certain radiation-emitting electronic products that have a medical use or make medical claims are also considered medical devices. Examples of these include diagnostic ultrasound products, x-ray machines and medical lasers.

Is a lab test a medical device?

What are lab tests? Laboratory tests are medical devices that are intended for use on samples of blood, urine, or other tissues or substances taken from the body to help diagnose disease or other conditions.

What are considered medical devices?

A medical device is an instrument, apparatus, implant, machine, tool, in vitro reagent, or similar article that is to diagnose, prevent, mitigate, treat, or cure disease or other conditions, and, unlike a pharmaceutical or biologic, achieves its purpose by physical, structural, or mechanical action but not through ...