Forensic Use Only
Express Diagnostics, Int’l, Inc. (“EDI”) products, used in the United States, labeled as FORENSIC USE ONLY are NOT for IN VITRO DIAGNOSTIC use and may not be used for medical or diagnostic purposes. A FORENSIC USE ONLY product MAY NOT be used in a clinical setting to diagnose or identify ailments, dependency or illness.
Products labeled for FORENSIC USE ONLY are tests that have not been cleared by the U.S. Food and Drug Administration (FDA) through the Section 510(k) pre-market notification process. FORENSIC USE ONLY devices 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 FDA’s intended exercise of enforcement discretion for Forensic Use Only products.
In the United States of America, FORENSIC USE ONLY products may only be sold to companies or agencies associated with the criminal justice system. These agencies include, but are not limited to, police, corrections, probation, parole and judicial courts and government agencies such as the Coast Guard, Department of Defense, Navy, Air Force, Army and Marines and laboratories performing forensic testing for these entities.
Products labeled as FORENSIC USE ONLY must NOT be distributed for “At Home” or “Over the Counter” use in the United States and its territories. The product must NOT be marketed or sold to end users through Internet distributions where the customer is unknown and may not fall into an allowable classification.