Identify Diagnostics USA 12 Panel Drug Test Cup with FEN & BUP - CLIA Waived

USA Made 12 Panel Drug Test Cup with 1 ng/mL Fentanyl

The Identify Diagnostics USA 12 Panel Drug Test Cup is a CLIA Waived rapid lateral flow immunoassay designed for preliminary qualitative drug screening in human urine. This updated configuration includes a highly sensitive fentanyl panel with a 1 ng/mL cutoff, along with buprenorphine and ten additional commonly screened drug classes.

Manufactured in the United States, the test combines specimen collection and drug screening in one convenient device. The integrated cup includes a secure screw-on lid, a built-in temperature strip, protected result panels beneath a peel-away label and clearly marked control and test lines.

Results are read at 5 minutes. A visible control line confirms that sufficient specimen volume, proper membrane wicking and correct procedural technique have occurred. A visible test line, even when faint, indicates that the drug concentration is below the stated cutoff. The absence of a test line with a valid control line indicates a preliminary positive result.

12 Panel Drug Configuration

AMP Amphetamine 500 ng/mL
BAR Barbiturates 300 ng/mL
BZO Benzodiazepines 300 ng/mL
BUP Buprenorphine 10 ng/mL
COC Cocaine 150 ng/mL
MDMA Ecstasy 500 ng/mL
FEN Fentanyl 1 ng/mL
THC Marijuana 50 ng/mL
MTD Methadone 300 ng/mL
MET Methamphetamine 500 ng/mL
MOR Morphine 300 ng/mL
OXY Oxycodone 100 ng/mL

Product Features

Made in the USA
CLIA Waived
FDA 510(k) cleared
Over-the-counter use
Results in 5 minutes
1 ng/mL fentanyl cutoff
Built-in temperature strip
Integrated specimen collection cup
Secure screw-on lid
Protected peel-away result label
Internal procedural control line
Single-use device
Designed for human urine only
Fresh urine requires no pretreatment

How the Test Works

The device uses competitive lateral flow immunoassay technology. Urine moves across each test strip by capillary action. When the concentration of a target drug is below the cutoff, a visible test line forms. When the concentration is at or above the cutoff, the test line does not form. The separate control line must appear for the result to be valid.

How to Use

Remove the test cup from its sealed pouch and use it within one hour of opening. Remove the lid and collect the urine specimen directly in the cup. Secure the lid, place the cup on a flat surface and start a timer. Peel back the result label and read the results at 5 minutes according to the included instructions.

Result Interpretation

Negative result: Two lines appear, one control line and one test line. Any visible test line, including a faint line, should be interpreted as negative.

Preliminary positive result: One control line appears and no test line appears for the applicable drug panel.

Invalid result: No control line appears. Repeat the test using a new device.

Important Testing Information

This device provides a preliminary qualitative screening result. A more specific analytical method should be used to obtain a confirmed result when required. GC/MS or LC/MS is the preferred confirmatory method.

A positive result indicates the presence of a drug or drug metabolite at or above the test cutoff. It does not determine drug concentration, route of administration or level of impairment. A negative result indicates that the concentration is below the cutoff and does not necessarily mean the specimen is drug-free.