“In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.” — Source: fda.gov
Devices or products listed on the Express Diagnostics website as “forensic use only” are not FDA cleared and may not be distributed or used for in-vitro medical diagnostic or treatment purposes. These products may not be distributed for “at home” or “over-the-counter” sales in the U.S. or its territories nor are they intended to be marketed or sold to end users via the Internet. Products labeled as “forensic use only” are only to be sold or distributed to law enforcement agencies, such as prisons, sheriffs’ departments or drug courts and are not to be sold or distributed to facilities such as hospitals, pain clinics, or employment agencies.