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Healgen HDOP-114 single-panel opiates urine drug test dip card

Single Panel Opiates (OPI) Drug Test Dip Card – 25/Box

$18.75

CLIA Waived
FDA 510(k) Cleared
OTC & Rx Use

25 tests per box$0.75 per test

Single-panel urine dip card for preliminary qualitative screening of opiates at a 2,000 ng/mL cutoff. Read results at 5 minutes.

  • Screens opiates (OPI) with morphine as the calibrator
  • Simple one-step dip-card format
  • Up to 99% accurate
  • Up to 24-month shelf life
Quantity Discounts
1-5 6-10 11+
$18.75 $17.25 $16.31

Single-Panel Opiates Drug Test Overview

The Healgen HDOP-114 is a single-use urine dip card for preliminary qualitative screening of opiates. The OPI assay is calibrated to morphine at a 2,000 ng/mL cutoff. Read results at 5 minutes. Each box contains 25 tests.

CLIA Waived
FDA 510(k) Cleared
OTC & Rx Use
25 Tests per Box

Features and Benefits

Single-panel OPI screeningScreens human urine for the opiates class at a 2,000 ng/mL cutoff.

Results at 5 minutesUse a timer and interpret the result at the time specified in the package insert.

One-step dip-card formatNo separate reagents are required to run the test.

Built-in procedural controlThe control line indicates that sufficient specimen volume and proper membrane flow occurred.

Up to 99% accurateThis original product-page claim depends on correct storage, testing and interpretation; performance can vary near the cutoff.

Up to 24-month shelf lifeFDA documentation supports 24-month stability at 2–30°C; always verify the expiration date on the sealed pouch.

Product Details

Reference
HDOP-114
SKU
DTK-109013
Sample
Human Urine
Package
25 Tests per Box

Manufacturer Healgen Scientific LLC
Test Format Single-panel urine dip card
Test Method Competitive lateral-flow immunoassay
Result Type Preliminary qualitative screening result
Analyte Opiates, calibrated to morphine
Cutoff 2,000 ng/mL
Read Time 5 minutes
Intended Use Over-the-counter and prescription use
Regulatory Status FDA 510(k) cleared; CLIA waived
Storage 2–30°C (36–86°F); do not freeze

Opiates Test and Cutoff

Drug Class Abbreviation Calibrator Cutoff
Opiates OPI Morphine 2,000 ng/mL

Drug-detection periods vary with the substance, cutoff, dose, frequency and timing of use, specimen collection, individual metabolism and other biological factors. A screening result does not determine impairment. Follow the package insert when performing and interpreting the test.

What This OPI Screen Detects

This OPI assay is calibrated to morphine and screens the opiates class at 2,000 ng/mL. Its response to individual opiate compounds varies according to the cross-reactivity described in the package insert.

This is not a dedicated fentanyl, oxycodone, buprenorphine or methadone assay. Use a separately labeled test when screening specifically for one of those analytes.

How to Perform the Test

Prepare the materialsBring the sealed test and urine specimen to the temperature specified in the package insert before testing.

Remove the testOpen the foil pouch only when ready to test, remove the dip card and take off the cap.

Dip for at least 15 secondsImmerse the arrow end in the urine specimen without allowing the urine level to pass the MAX line.

Lay flat and readRemove the dip card, replace the cap, place the device on a clean non-absorbent surface and read the result at 5 minutes.

Understanding the Results

NegativeTwo lines appear: one control line at C and one test line at T. Any visible test line is interpreted as negative, even when faint.

Preliminary positiveThe control line appears at C, but no test line appears at T. Confirm the result with a more specific laboratory method.

InvalidNo control line appears. Repeat the test with a new device and follow the package insert carefully.

Screening notice: This device provides only a preliminary qualitative result. A more specific alternative method, such as GC/MS or LC/MS, must be used to confirm a preliminary positive result. Careful consideration and professional judgment should be applied to every drug-screening result.

Storage and Shelf Life

Store the unopened test at 2–30°C (36–86°F). Do not freeze, keep the test sealed until use and do not use it after the expiration date printed on the pouch. FDA documentation reports 24-month stability under the specified storage conditions.

Regulatory Document

FDA 510(k) K240686

Frequently Asked Questions

What does the HDOP-114 dip card screen for?

HDOP-114 screens human urine for the opiates class at a 2,000 ng/mL cutoff and is calibrated to morphine.

Is this opiates drug test CLIA waived?

Yes. The product is listed as CLIA waived.

Is HDOP-114 intended for over-the-counter use?

Yes. FDA AccessGUDID identifies HDOP-114 for both over-the-counter and prescription use.

How quickly are results available?

Read the result at 5 minutes and follow the current package insert for the permitted interpretation window.

Does this OPI test detect every opioid?

No. This is a morphine-calibrated opiates class screen. It is not a dedicated test for fentanyl, oxycodone, buprenorphine or methadone; use separately labeled assays when screening specifically for those analytes.

What does a faint test line mean?

When the control line is present, any visible test line is interpreted as negative, even when the test line is faint.

Does a preliminary positive result require confirmation?

Yes. A preliminary positive screening result must be confirmed with a more specific laboratory method such as GC/MS or LC/MS.

How should the tests be stored?

Store the sealed tests at 2–30°C (36–86°F), do not freeze and verify the expiration date on each pouch before use.

How many tests are included?

Each box contains 25 single-use opiates drug test dip cards.

What does “up to 99% accurate” mean?

The existing product listing states that the test is up to 99% accurate. Actual agreement varies with specimen concentration, particularly near the cutoff, and depends on correct storage, testing and interpretation. The result remains preliminary.

Need to Test a Substance or Residue?

This urine dip card is designed to test a human urine specimen. For presumptive identification of an unknown substance or residue, review the separate DABIT opiates product.

View DABIT Opiates Test

Workplace Drug-Testing Resources

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 1 lbs
Dimensions 6 × 5 × 3 in

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