12 Panel Dip Test CLIA Waived Drug Screen – 25/Box (AMP / BAR / BUP / BZO / COC / mAMP / MDMA / MOP / MTD / OXY / PCP / THC)

$113.75

CLIA Waived
FDA 510(k) Cleared
OTC

25 tests per box

$4.55 per test

Healgen 12-panel urine drug test dip card for the qualitative detection of 12 drugs and drug metabolites. The HDOA-6125 configuration provides results at five minutes and includes a 300 ng/mL morphine cutoff.

  • Screens AMP, BAR, BUP, BZO, COC, MDMA, MET, MOP, MTD, OXY, PCP and THC
  • CLIA-waived and FDA 510(k) cleared under K240686
  • OTC and prescription-use configuration
  • 25 individually pouched dip cards per box
Quantity Discounts
1-5 6-10 11+
$113.75 $104.65 $98.96

12-Panel Urine Drug Test Dip Card

The Healgen HDOA-6125 is a 12-panel lateral-flow dip card for the qualitative detection of multiple drugs and drug metabolites in human urine. This exact configuration screens for AMP, BAR, BUP, BZO, COC, MDMA, MET, MOP, MTD, OXY, PCP and THC at the cutoff concentrations shown below. Results are preliminary and require laboratory confirmation when a definitive result is needed.

CLIA Waived
FDA 510(k) Cleared
OTC
12-Panel Screening
25 Tests per Box

Features and Benefits

12-panel screening
Screens one urine specimen for 12 drugs and drug metabolites.

Results at five minutes
Provides rapid, visually interpreted preliminary screening results.

One-step dip-card format
Dip the absorbent end directly into a properly collected urine specimen.

Current MOP300 configuration
The exact HDOA-6125 device uses a 300 ng/mL morphine cutoff.

Product Details

Reference
HDOA-6125
SKU
DTK-158121

Manufacturer Healgen Scientific LLC
Test format Multi-panel urine dip card
Specimen Human urine
Number of panels 12
Result time Five minutes
Regulatory status FDA 510(k) cleared under K240686; CLIA waived; OTC and prescription use
Package size 25 tests per box
Storage 2–30°C (36–86°F); do not freeze

Drugs and Cutoff Concentrations

Drug or Drug Metabolite Abbreviation Cutoff
Amphetamine AMP 1,000 ng/mL
Barbiturates / Secobarbital BAR 300 ng/mL
Buprenorphine BUP 10 ng/mL
Benzodiazepines / Oxazepam BZO 300 ng/mL
Cocaine / Benzoylecgonine COC 300 ng/mL
Ecstasy MDMA 500 ng/mL
Methamphetamine MET 1,000 ng/mL
Morphine MOP 300 ng/mL
Methadone MTD 300 ng/mL
Oxycodone OXY 100 ng/mL
Phencyclidine PCP 25 ng/mL
Marijuana metabolite THC 50 ng/mL
Important: Cutoff concentrations are screening thresholds and are not estimates of how long a substance remains detectable. Detection periods vary according to the substance, frequency and amount of use, specimen collection time, metabolism and other biological factors.

How to Perform the Test

  1. Allow the sealed test device and urine specimen to reach room temperature when necessary.
  2. Collect fresh urine in a clean, dry specimen container.
  3. Remove the dip card from its sealed pouch.
  4. Dip the absorbent end into the urine with the arrows pointing toward the specimen. Do not allow the urine to rise above the maximum line.
  5. Leave the absorbent end in the urine for at least 15 seconds, then place the device on a clean, flat, nonabsorbent surface.
  6. Read the results at five minutes and follow the instructions supplied with the current product lot.

Understanding the Results

Result Interpretation
Negative A control line and a test line appear for the applicable drug panel. A faint visible test line should be interpreted as negative.
Preliminary positive The control line appears, but no test line appears for the applicable drug panel.
Invalid The control line does not appear. Review the procedure and repeat the test with a new device.
Confirmation required: This device provides only preliminary qualitative screening results. A more specific analytical method, such as GC-MS or LC-MS, must be used to obtain a confirmed positive result.

Instructions and Regulatory Documents

Document notice: The existing manufacturer PDF is an older general dip-card insert that lists morphine at 2,000 ng/mL. The current FDA device record for HDOA-6125 specifies MOP at 300 ng/mL. Use the instructions and cutoff information supplied with the current product lot, and replace the older PDF when an updated HDOA-6125 insert becomes available.

Frequently Asked Questions

Which drugs does HDOA-6125 screen for?

It screens for amphetamine, barbiturates, buprenorphine, benzodiazepines, cocaine, MDMA, methamphetamine, morphine, methadone, oxycodone, phencyclidine and marijuana metabolite.

What is the morphine cutoff for this configuration?

The current exact HDOA-6125 device record specifies a morphine cutoff of 300 ng/mL.

How quickly are results available?

Results are read at five minutes. Always follow the instructions supplied with the current product lot.

Is HDOA-6125 CLIA-waived?

Yes. This HDOA-6125 configuration is identified as a CLIA-waived urine drug test dip card.

Is HDOA-6125 an OTC test?

Yes. The exact FDA AccessGUDID record for HDOA-6125 identifies the device for both prescription and over-the-counter use.

Does a preliminary positive result require confirmation?

Yes. A preliminary positive result should be confirmed using a more specific analytical method, such as GC-MS or LC-MS, in accordance with applicable policies and requirements.

How many tests are included?

Each box contains 25 single-use, 12-panel urine drug test dip cards.

Additional information

Weight 1 lbs
Dimensions 6 × 5 × 3 in
Panels

12

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