Forensic Use Only
Forensic Use Only
Forensic Use Only devices are not intended by the manufacturer to be used for any in vitro diagnostic applications and are clearly labeled and marked "For Forensic Use Only" or equivalent. Such devices are to be sold to court systems, police departments, probation/parole offices, juvenile detention centers, prisons, jails, correction centers and other similar law enforcement entities, or to laboratories performing forensic testing for these entities.
Devices or products listed on the Test Kits USA website as "Forensic Use Only" are not FDA 510(k) cleared and should not be distributed or used for in-vitro medical diagnostic or treatment purposes. These products should 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.
*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