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AllTest DFY-A102C CLIA-waived fentanyl urine test cassette
Fentanyl Urine Test Cassette CLIA-Waived

Fentanyl Urine Test Cassette – CLIA Waived – 25/Box

$56.25

CLIA Waived
FDA 510(k) Cleared

25 tests per box
•
$2.25 per test

Professional-use, single-panel urine test cassette for the qualitative detection of fentanyl at a 1 ng/mL cutoff. Read results at five minutes and do not interpret them after 10 minutes.

  • Detects fentanyl in human urine at 1 ng/mL
  • CLIA-waived professional-use configuration
  • Test cassette and disposable dropper included
  • Preliminary screening results in five minutes
Quantity Discounts
1-5 6-10 11+
$56.25 $51.75 $48.94

Fentanyl Urine Test Cassette Overview

The AllTest Fentanyl Urine Test Cassette is a competitive-binding lateral-flow immunoassay for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1 ng/mL. This single-panel cassette provides preliminary screening results in five minutes and is supplied in boxes of 25 tests.

CLIA Waived
FDA 510(k) Cleared
1 ng/mL Cutoff
25 Tests per Box
Professional-use configuration: This page is for reference DFY-A102C, the professional/CLIA-waived configuration. It should not be represented as the DFY-A102H OTC home-use version.

Features and Benefits

✓

Low 1 ng/mL cutoff
Qualitatively detects fentanyl in human urine at the stated cutoff concentration.

✓

Results in five minutes
Read the result at five minutes and do not interpret it after 10 minutes.

✓

Simple cassette procedure
Transfer three full drops of urine into the cassette specimen well using the supplied dropper.

✓

Instrument-free screening
Results are interpreted visually without a separate reader or analyzer.

Product Details

Reference
DFY-A102C
SKU
DTK-108102

Manufacturer Hangzhou AllTest Biotech Co., Ltd.
Test format Single-panel cassette
Specimen Human urine
Analyte Fentanyl
Abbreviation FYL
Cutoff 1 ng/mL
Result time Read at five minutes; do not read after 10 minutes
Regulatory status FDA 510(k) cleared under K231698; CLIA waived
Package size 25 tests per box

How to Perform the Test

  1. Allow the test cassette and urine specimen to reach room temperature before testing.
  2. Collect the urine specimen in a clean, dry collection container.
  3. Remove the cassette and dropper from the sealed pouch and place the cassette on a clean, level surface.
  4. Hold the dropper vertically and transfer three full drops of urine into the specimen well marked “S.”
  5. Start the timer and read the result at five minutes. Do not interpret the result after 10 minutes.

Understanding the Results

Result Interpretation
Negative Two colored lines appear: one in the control region and one in the test region. A visible test line should be interpreted as negative regardless of its color intensity.
Preliminary positive One colored line appears in the control region and no line appears in the test region.
Invalid The control line does not appear. Repeat the test with a new cassette.
Important: This test provides only a preliminary screening result. A more specific analytical method must be used to obtain a confirmed result. The manufacturer identifies GC/MS or LC/MS as the preferred confirmation methods.

What Is Included?

  • 25 individually pouched fentanyl test cassettes
  • Disposable droppers
  • User instructions

A clean, dry urine collection cup and a timer are required but are not provided.

Storage

Store the test in its sealed pouch at 35.6–86°F (2–30°C) until the expiration date printed on the packaging. Keep it away from direct sunlight, moisture and heat. Do not freeze.

Instructions and Regulatory Documents

Fentanyl Test Package Insert

Frequently Asked Questions

What does this fentanyl cassette detect?

It qualitatively screens human urine for fentanyl at a cutoff concentration of 1 ng/mL.

How quickly are results available?

Read the result at five minutes. Do not interpret the result after 10 minutes.

Is DFY-A102C CLIA-waived?

Yes. DFY-A102C is the professional CLIA-waived configuration. Facilities performing patient testing should follow all applicable CLIA requirements and the package insert.

Is this the OTC fentanyl test?

No. This listing is for DFY-A102C, the professional-use configuration. The similar DFY-A102H reference is the OTC home-use configuration and should not be confused with this product.

Does a positive result confirm fentanyl use?

No. A positive result is preliminary and must be confirmed using a more specific analytical method. The manufacturer identifies GC/MS or LC/MS as the preferred confirmation methods.

How many tests are included?

Each box contains 25 single-use fentanyl urine test cassettes with disposable droppers and user instructions.

Looking for Workplace Testing Information?

Drug-testing requirements vary by employer, industry and jurisdiction. Review applicable federal, state and local requirements before implementing a workplace testing program.

Review SAMHSA Workplace Resources

Additional information

Weight 6 lbs
Dimensions 15 × 15 × 4.5 in

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