*Statement on Forensic Use Products
Forensic Use Only devices are intended for use only in drugs of abuse testing for law enforcement purposes.
Appropriate users of such devices include, for example, court systems, police departments, probation/parole offices, juvenile detention centers, prisons, jails, correction centers and other similar law enforcement entities, or laboratories or other establishments performing forensic testing for these entities.
Forensic Use Only devices are not designed, tested, developed, or labeled for use in other settings, such as clinical diagnostic or workplace settings.
The CEDIA® UR-144/XLR-11 Assay is a homogenous enzyme immunoassay for the qualitative and semi-quantitative determination for the presence of UR-144/XLR-11 and their metabolites in human urine at a cutoff concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a simple and rapid analytical screening procedure to detect UR-144/XLR-11 and their metabolites in human urine.
The semi-quantitative mode is for the purpose of detection and enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. For Criminal Justice and Forensic Use Only.