INDICAID Fentanyl Drug Detection Test

A rapid, one-step immunoassay for the
qualitative detection of fentanyl in human
urine.

CLIA Waived.
For in vitro diagnostic use.
Medical and other professional in vitro diagnostic use labeling.

About

The INDICAID Fentanyl Drug Detection Test is a rapid, one-step immunoassay for the qualitative detection of fentanyl in human urine at the cutoff concentrations of 1 ng/mL. With the growing need for effective substance use monitoring, this point-of-care test provides quick and reliable results, empowering healthcare professionals to take immediate action and improve patient outcomes.

Who Is It For?

Healthcare providers managing patients suspected of fentanyl use, to quickly confirm or rule out fentanyl exposure.
Clinicians working in addiction recovery programs, to monitor and assess fentanyl presence in patients undergoing treatment.
Law enforcement professionals conducting investigations or handling criminal justice cases involving suspected drug use, to provide rapid on-site confirmation of fentanyl presence.

Specifications

Components	Test devices packaged individually in a foil pouch with desiccant and package insert
Test type	Rapid Lateral Fluid Immunoassay for the detection of fentanyl in human urine
Tests per kit	25
Specimen type	Urine sample
Result time	5 Minutes
Urine cutoff	1 ng/mL
FDA status	510(k) cleared

Intended Use

The INDICAID Fentanyl Drug Detection Test is a rapid, one-step immunoassay for the qualitative detection of fentanyl in human urine at the cutoff concentrations of 1 ng/mL.

This device provides only preliminary drug test results. To obatin a quantitative result or a confirmation of a presumptive positive result, a more specific alternative method must be used. GC/MS or LC/MS is the preferred confirmatory method.

Professional judgement should be applied to drug test results, particularly when preliminary positive results are indicated.