Identify Diagnostics

1 Panel FEN Fentanyl Drug Test Cassette CLIA Waived - Identify Diagnostics

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Currently on backorder. Pre-order now to have your place in line.
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Expected release date is 5th Jan 2024

Now: $48.25
Was: $55.00


Identify Diagnostics FEN Fentanyl Drug Test Cassette - BOXES OF 25 TESTS - CLIA Waived

The current expiration date for this drug test cassette is on or better than: MAY 31, 2025

Currently on backorder. Pre-order now to have your place in line.

- CLIA Waived Fentanyl Test
- FDA Cleared 510K for OTC Over The Counter
- Purchase in bulk or small quantities to meet your specific volume needs
- Join our flexible auto-ship program to help make reordering easy
- For larger volume pricing please call 727-744-2967

Drugs Tested:
FEN - Fentanyl 1 ng/ml Cut-off Level

This single panel drug test cassette is a lateral flow chromatographic Immunoassay for the qualitative detection of fentanyl metabolites in human urine.  

For the Identify Diagnostics drug test package CLIA Waived insert please click the icon below:

Identify Diagnostics, a renowned leader in the field of diagnostic testing, has introduced a groundbreaking product that has received both CLIA Waived designation and FDA 510(k) clearance: the Over-The-Counter (OTC) Fentanyl Urine Drug Test. This innovative device offers an accessible and convenient solution for individuals concerned about potential Fentanyl exposure, as well as for healthcare professionals and organizations looking to enhance patient care and safety.

Fentanyl, a potent synthetic opioid, has gained notoriety for its role in the opioid epidemic. It is many times more potent than morphine and is often associated with a high risk of overdose and death. Given its prevalence on the illicit drug market and the potential for accidental exposure, having a reliable and user-friendly Fentanyl drug test available over the counter is a significant advancement in addressing this public health concern.

Key features of Identify Diagnostics' OTC Fentanyl Drug Test: 

CLIA Waived Designation: The Clinical Laboratory Improvement Amendments (CLIA) Waived designation is a crucial regulatory approval from the Centers for Medicare & Medicaid Services (CMS). This status means that the test can be safely and accurately conducted outside of a traditional clinical laboratory setting, allowing for widespread access and convenience.

FDA 510(k) Clearance: The FDA 510(k) clearance is a rigorous and essential process that ensures the safety and effectiveness of medical devices. This clearance demonstrates that Identify Diagnostics' OTC Fentanyl Drug Test meets the high standards set by the FDA for accuracy and reliability.

Easy-to-Use: The OTC Fentanyl Drug Test Cassette is designed to be user-friendly, requiring no special training or expertise to administer. It comes with clear and simple instructions, making it accessible to individuals who may be concerned about Fentanyl exposure.

Rapid Results: Within 5 mintues, this test provides rapid results, allowing individuals and healthcare professionals to quickly determine if Fentanyl is present in a sample.

High Sensitivity and Specificity: The test is designed to detect even trace amounts of Fentanyl at 1 ng/mL, ensuring that it can accurately identify potential exposure. 
Privacy and Discreetness: The OTC Fentanyl Drug Test offers a discreet and private solution for individuals who want to check for Fentanyl without involving healthcare professionals or labs.

Reliability and Peace of Mind: This test offers peace of mind for individuals who may be worried about potential Fentanyl exposure due to environmental contamination, drug use, or other sources.

Identify Diagnostics' OTC Fentanyl Drug Test represents a significant advancement in the fight against Fentanyl-related harm. Its CLIA Waived status and FDA 510(k) clearance underscore its accuracy and reliability, making it a valuable tool for individuals and healthcare providers alike. By offering accessible and convenient testing options, Identify Diagnostics is contributing to a safer and more informed community, ultimately helping to address the ongoing opioid crisis.



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Additional Information

CLIA Waived:
CLIA Waived
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