CLIA Waived 12 Panel Drug Test Cup with Fentanyl 1 ng/mL

CLIA Waived 12 Panel Drug Test Cup with Fentanyl 1 ng/mL

The 12 panel drug test cup with fentanyl combines urine collection and 12 preliminary drug screens in one 120 mL device. Urine is collected directly into the cup, so the specimen does not need to be transferred to a separate test device.

What sets this configuration apart is sensitivity. The fentanyl panel uses a 1 ng/mL cutoff, and amphetamine, cocaine and methamphetamine are screened at 500, 150 and 500 ng/mL instead of the 1000/300/1000 ng/mL cutoffs used on many standard cups.

The cup is labeled CLIA-waived. Buyers who need a different combination can compare all 12 panel drug test cups.

12 Panel Drug Test List and Cutoff Levels

Compare both the target and the cutoff when choosing a configuration. Products with a similar name or panel count can use different cutoff levels.

Serenity 120 mL Click Cup Features

The Serenity click cup uses a secure click-top lid that helps prevent leaks during handling. A built-in temperature strip provides a specimen-temperature reference shortly after collection.

All 12 test panels are built into the cup, which keeps collection and screening in one step and reduces handling of the specimen.

For a broader overview of standard panels, see our article on what a 12 panel drug test detects.

Fentanyl and Opioid Screening Panels

Opioid coverage is the main reason buyers choose this configuration.

BUP/10 screens for buprenorphine, which is commonly monitored in medication-assisted treatment programs.

MTD/300 screens for methadone, which is commonly monitored in opioid treatment programs.

OXY/100 screens for oxycodone, a semi-synthetic opioid that standard opiate panels may not detect at typical cutoffs.

FEN/1 is a dedicated fentanyl assay. Fentanyl is a synthetic opioid that a standard OPI (morphine) panel is not designed to detect, so a separate fentanyl panel is needed when fentanyl screening is required.

Learn more about fentanyl detection in urine tests.

How to Use and Read Results

Always follow the package insert supplied with the exact lot, because collection steps and reading times can differ between devices.

1. Bring the sealed cup and the specimen to room temperature as directed in the package insert.
2. Collect urine directly into the cup to the required level and close the lid securely.
3. Check the built-in temperature strip within the time stated in the insert.
4. Activate or expose the test panels as directed and start timing.
5. Read each panel within the interpretation window stated in the insert; do not read results after that window.

• Negative: both the control line (C) and the test line (T) appear for each panel. A faint test line is interpreted according to the insert.
• Non-negative (preliminary positive): the control line appears but the test line does not. This is a preliminary screening result, not a confirmed result.
• Invalid: no control line appears. Do not interpret the result; repeat the test with a new device.

A non-negative screen should be followed by laboratory confirmation according to your program’s procedure before any final decision is made. A screening result does not show impairment, dose or the time of use.

For a step-by-step explanation of line-based results, see our guide on how to read a drug test cup.

Who Uses This 12 Panel Fentanyl Cup?

This 12 panel drug test cup is labeled CLIA-waived. Typical buyers include:

• Physician offices, urgent care and occupational health clinics
• Addiction treatment, MAT and recovery programs
• Employers and third-party administrators running non-DOT programs
• Community and public-health testing programs

A CLIA-waived test still has to be performed under the appropriate CLIA certificate. See the CMS CLIA program and our guide to CLIA-waived vs. non-waived tests.

Intended Use, Storage & Limitations

This cup is labeled CLIA-waived. CLIA status belongs to the specific test system, so it should not be assumed for other products with a similar name or panel count.

Store sealed pouches as directed on the packaging, check the expiration date before use and use each device only once.

This is a preliminary screening test: it detects only the targets listed above at the stated cutoffs. As the FDA guidance on drugs-of-abuse screening tests explains, preliminary positive results should be confirmed by a laboratory. Instant tests are not an authorized method for DOT-regulated drug testing under 49 CFR §40.210.

Bulk & Wholesale 12 Panel Drug Test Cups with Fentanyl

DrugTestingCup.com sells the 12 panel drug test cup with fentanyl with quantity-based pricing: the larger the order, the lower the price per cup. FREE SHIPPING applies to orders of 100 cups or more, and eligible in-stock orders placed before 3 PM EST ship the same business day.

Treatment programs, correctional facilities, clinics, resellers and distributors with recurring or high-volume orders can contact our team for wholesale pricing. Before ordering, compare other options in our CLIA-waived drug test cups.

Frequently Asked Questions

What does this 12 panel drug test cup with fentanyl test for?

It screens for AMP/500, BAR/300, BUP/10, BZO/300, COC/150, MDMA/500, MET/500, MTD/300, OPI/300, OXY/100, THC/50 and FEN/1.

What is the fentanyl cutoff on this cup?

The fentanyl panel has a 1 ng/mL cutoff, which is more sensitive than the 20 ng/mL fentanyl panels found on many cups.

Is this 12 panel cup CLIA waived?

Yes. This configuration is labeled CLIA-waived. The testing site still needs the appropriate CLIA certificate.

Does the OPI panel detect fentanyl?

No. Fentanyl is screened by its own FEN/1 panel because standard opiate panels are not designed to detect it.

Can this cup be used for DOT drug testing?

No. Instant urine tests are not authorized for DOT-regulated testing under 49 CFR §40.210.

Is bulk pricing available?

Yes. Per-cup pricing drops with quantity, and orders of 100 cups or more ship free.