12 Panel CLIA Waived Multi Drug Screen Dip Test – 25/Box (AMP / BAR / BUP / BZO / COC / mAMP / MDMA / MTD / OPI / OXY / PCP / THC)
$112.50
FDA 510(k) Cleared
OTC & Rx Use
25 tests per box$4.50 per test
One-step, over-the-counter urine dip card for the qualitative screening of 12 drugs and drug metabolites. Read preliminary results at 5 minutes.
- Screens AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MTD, OPI, OXY, PCP and THC
- Single-use dip-card format for human urine
- Up to 99% accurate when stored, performed and interpreted according to the package insert
- Up to 24-month shelf life; verify the expiration date on each sealed pouch
| 1-5 | 6-10 | 11+ |
| $112.50 | $103.50 | $97.88 |
12-Panel CLIA-Waived Drug Test Dip Card
The Wondfo WDOA-6124 is a single-use, one-step lateral-flow urine test for the qualitative screening of 12 drugs and drug metabolites. Its exact panel includes AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MTD, OPI, OXY, PCP and THC. Preliminary results are read at 5 minutes, and each box contains 25 individually pouched test devices.
FDA 510(k) Cleared
OTC & Rx Use
25 Tests per Box
Features and Benefits
Product Details
WDOA-6124
DTK-209122
Human Urine
25 Tests per Box
| Specification | Details |
|---|---|
| Manufacturer | Wondfo USA Co., Ltd. |
| Test format | One-step 12-panel urine dip card |
| Test method | Competitive-binding lateral-flow immunochromatographic assay |
| Result type | Preliminary qualitative screening result |
| Read time | Read at 5 minutes; do not interpret after 30 minutes |
| Intended use | Over-the-counter and prescription use |
| Regulatory status | CLIA waived; FDA 510(k) cleared under K133968 |
| Storage | 39–86°F (4–30°C); do not freeze |
Drug Panel and Cutoff Levels
This WDOA-6124 configuration uses the following analytes and cutoff concentrations. The OPI strip uses a 2,000 ng/mL cutoff; it is not the MOP 300 ng/mL configuration used in some other Wondfo 12-panel devices.
| Detectable Drug or Drug Class | Abbreviation | Cutoff |
|---|---|---|
| Amphetamine | AMP | 1,000 ng/mL |
| Barbiturates | BAR | 300 ng/mL |
| Buprenorphine | BUP | 10 ng/mL |
| Benzodiazepines | BZO | 300 ng/mL |
| Cocaine metabolite | COC | 300 ng/mL |
| Ecstasy | MDMA | 500 ng/mL |
| Marijuana metabolite | THC | 50 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Methamphetamine | mAMP/MET | 1,000 ng/mL |
| Opiates | OPI | 2,000 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
This screening test provides preliminary qualitative results and does not measure impairment, intoxication, dose or the time a substance was used. A more specific alternative method such as GC/MS or LC/MS must be used to confirm a presumptive positive result.
How to Perform the Test
Understanding the Results
Storage and Handling
Instructions and Regulatory Documents
Use the current insert and the package insert included with the purchased lot for test procedures and interpretation. The legacy insert is retained as a product-specific historical document but contains an older result-reading limit.
Legacy WDOA-6124 Package Insert
FDA 510(k) K133968
FDA AccessGUDID Device Record
Frequently Asked Questions
What does the WDOA-6124 test screen for?
It screens urine for AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MTD, OPI, OXY, PCP and THC at the cutoffs listed on this page.
Is this 12-panel drug test CLIA waived?
Yes. The current Wondfo T-Dip package insert identifies the test system as CLIA waived when used according to its instructions.
Is WDOA-6124 an over-the-counter test?
Yes. The FDA AccessGUDID record for exact model WDOA-6124 identifies it for both over-the-counter and prescription use.
Does this configuration use OPI or MOP?
WDOA-6124 uses OPI at a 2,000 ng/mL cutoff. It should not be described as the MOP 300 ng/mL configuration found in WDOA-6125 and other variations.
How quickly are results available?
Read the test at 5 minutes. Under the current 2021 insert, results should not be interpreted after 30 minutes.
What specimen is required?
This test is designed for a freshly collected human urine specimen. Follow the package insert for specimen collection, storage and handling requirements.
What does a faint test line mean?
Any visible test line should be interpreted as negative when the control line is present, regardless of line intensity. Do not compare line darkness between analytes.
Does a preliminary positive result require confirmation?
Yes. A presumptive positive screening result should be confirmed using a more specific analytical method such as GC/MS or LC/MS.
How many tests are included?
Each box contains 25 single-use WDOA-6124 urine drug-test dip cards.
How accurate is the test, and what is its shelf life?
The product is described as up to 99% accurate and may have a shelf life of up to 24 months when stored correctly. Performance depends on following the package insert, and the expiration date on the sealed pouch should always be verified.
Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 6 × 5 × 3 in |
