Products that are labeled Forensic Use Only (FUO) are NOT for IN VITRO Diagnostic use and may not be used for medical or diagnostic purposes. A FUO product may not be used in a clinical setting to diagnose or identify ailments, dependency, or illness.
All products labeled FUO are tests that have not been cleared by the U.S. Food and Drug Administration (FDA) through section 510(k) pre-market notification process. FUO test kits are not designed, tested, developed, or labeled for use in other settings such as clinical diagnostics or other non-law enforcement settings, which fall outside of the scope of the FDA's intended exercise of enforcement discretion for FUO products.
In the U.S. FUO products may only be sold to companies or agencies associated with the criminal justice system and some devices may now be available for Insurance and Employment use. These criminal justice agencies include but are not limited to police, corrections, probation, parole, and judicial courts and government agencies such as Coast Guard, Department of Defense, Army, Navy, Marines, and Air Force and laboratories performing forensic testing for these entities.
If you have questions on whether or not you qualify please call 800-331-2716 to speak with a sales representative.
To complete the form online click here.
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