CLIA Waived 15 Panel Drug Test Cup with FEN, NFYL & EDDP

CLIA Waived 15 Panel Drug Test Cup

This CLIA waived 15 panel drug test cup provides preliminary urine screening for 15 drugs and drug metabolites in one 90ml collection device. Its distinguishing configuration includes fentanyl at 1 ng/mL, norfentanyl at 5 ng/mL and EDDP at 300 ng/mL.

The separate FEN, NFYL, MTD and EDDP panels make this cup suitable for qualified testing programs that require broader opioid-related screening alongside commonly tested drug classes.

Product Features

• Screens for 15 drugs and drug metabolites
• Includes FEN/1 and NFYL/5
• Includes MTD/300 and EDDP/300
• Compact 90ml urine collection cup
• Built-in temperature strip
• Results in approximately five minutes
• No separate testing equipment required
• CLIA-waived configuration
• Volume pricing for recurring and bulk orders

15 Panel Drug Test, Test For:

A cutoff is the concentration used to distinguish a negative screening result from a preliminary non-negative result. Review our drug test cutoff level guide for additional information about screening thresholds.

Fentanyl and Norfentanyl Screening

Fentanyl and norfentanyl are separate screening targets. Fentanyl is the parent substance, while norfentanyl is a primary metabolite produced after fentanyl is processed by the body.

This cup includes both:

• FEN at 1 ng/mL
• NFYL at 5 ng/mL

An ordinary OPI panel should not be assumed to detect fentanyl or norfentanyl. Buyers requiring these targets should select a configuration that explicitly lists FEN and NFYL.

Methadone and EDDP Panels

The cup also includes separate MTD/300 and EDDP/300 panels. MTD screens for methadone, while EDDP targets a primary methadone metabolite.

Including both targets can provide broader preliminary screening information than a cup containing only an MTD panel. Results remain qualitative and should not be used to determine the amount consumed, exact time of use or medication compliance without appropriate professional review.

What CLIA Waived Means

CLIA-waived status applies to a specific test system and configuration. It means the test can be performed by laboratories operating under a CLIA Certificate of Waiver, as well as facilities holding other appropriate CLIA certificate types, when the manufacturer’s instructions and applicable requirements are followed.

CLIA-waived status does not automatically mean that a product is approved for unrestricted home use. Home or over-the-counter use should only be stated when the labeling for the exact device supports that claim.

Facilities should verify:

• The precise product and configuration are CLIA waived
• Their CLIA certificate covers their testing activities
• Personnel follow the current package insert
• Quality-control and recordkeeping procedures are maintained
• Applicable state and local requirements are satisfied

Healthcare providers can review the official CMS CLIA application information when determining their certificate requirements.

How to Use the Test Cup

1. Review the package insert and confirm the analyte configuration.
2. Collect the required urine specimen directly in the cup.
3. Secure the lid and place the cup upright on a level surface.
4. Check the temperature indicator within the time stated in the instructions.
5. Allow the test to develop for approximately five minutes.
6. Read every panel within the manufacturer’s specified interpretation window.
7. Record the results according to your facility’s testing procedure.

For most competitive immunoassay panels:

• A control line and test line indicate a negative result below the cutoff.
• A faint test line is generally interpreted as negative when the control line is present.
• A control line without a test line indicates a preliminary non-negative result.
• An absent control line means that panel is invalid.

Always follow the instructions supplied with the exact device. Our illustrated guide explains how to read a drug test cup in greater detail.

Comparing CLIA-Waived Configurations

Choose this 15-panel configuration when your program requires both fentanyl and norfentanyl screening together with PCP and EDDP.

The CLIA waived 14 panel drug test cup contains FEN/1, EDDP/300 and TCA/1000 but does not include the NFYL/5 or PCP/25 panels found in this product.

Buyers can also:

• Compare all 15 panel drug test cup configurations
• Browse additional CLIA-waived drug test cups

Do not select a cup based only on its panel count. Compare every analyte, cutoff and regulatory designation before ordering.

Preliminary Results and Confirmation

This cup provides qualitative preliminary screening results. It does not establish impairment, diagnose a substance-use disorder or determine exactly when or how much of a substance was consumed.

Prescription medications, cross-reactivity, specimen conditions and other factors can affect screening results. Preliminary non-negative results that may influence treatment, employment, legal status or another significant decision should be confirmed using an appropriate laboratory method.

Detection periods vary by substance, dose, frequency of use, metabolism, specimen and cutoff. The drug detection time guide provides general educational information but cannot predict an exact detection period for an individual.

Bulk CLIA-Waived Drug Test Cups

Quantity-based pricing is available for treatment programs, healthcare organizations, occupational testing providers, correctional programs and other high-volume buyers.

Qualifying orders of 100 or more cups receive free shipping. Eligible in-stock orders placed before 3:00 p.m. EST can ship the same business day. Confirm current inventory, expiration dating and delivery requirements before placing a large order.

Organizations needing recurring quantities can review our wholesale drug testing supplies.

Frequently Asked Questions

What does this CLIA waived 15 panel cup test for?

It screens for AMP, BAR, BUP, BZO, COC, MDMA, MET, OPI, MTD, OXY, THC, PCP, FEN, NFYL and EDDP at the cutoffs shown in the product table.

What is the difference between FEN and NFYL?

FEN targets fentanyl, while NFYL targets norfentanyl, a primary fentanyl metabolite. They are separate screening panels with different cutoff concentrations.

Why does the cup include both MTD and EDDP?

MTD screens for methadone, while EDDP screens for a primary methadone metabolite. Including both panels provides broader preliminary screening coverage than using an MTD panel alone.

Does CLIA waived mean the cup is approved for home use?

No. CLIA-waived status does not automatically establish home or over-the-counter clearance. Home use should only be claimed when supported by the labeling for the exact device.

Does a facility need a CLIA Certificate of Waiver?

Facilities performing human diagnostic testing generally need the appropriate CLIA certificate. A CLIA-waived test may be performed under a Certificate of Waiver or another applicable CLIA certificate when all requirements and manufacturer instructions are followed.

Does this cup include adulteration testing?

No separate pH, specific gravity or creatinine panels are listed. The built-in temperature strip is a collection check and should not be represented as a complete adulteration test.

Are preliminary non-negative results definitive?

No. Rapid cup results are preliminary. A non-negative result that may lead to a consequential decision should be reviewed under the applicable testing policy and confirmed using an appropriate laboratory method.