Have you ever heard someone say: “This test is CLIA-Waived,” but do not really know what that means?

Waived tests include test systems cleared by the FDA (Federal Food and Drug Administration) for home use and those tests approved for waiver under the CLIA (Clinical Laboratory Improvement Amendment Program) criteria. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof.

When taking a CLIA-Waived drug test, it’s important that it is taken correctly, following the manufacturer’s exact instructions, avoiding anything that can possibly alter the results. In just a few minutes you will be able to get quick results. The accuracy of your results will depend on the correct administration of the test and the quality of the test.

At Halux Diagnostic, we offer a wide variety of high quality drug testing products to be used at home. All of our drug tests have been through extensive trials, making them have a 99% level of accuracy.

Examples of CLIA-Waived drug tests include:
• Drug test dip cards
• Drug test cups

CLIA requirements apply to the clinical use of drug testing. This includes any entity that performs tests on materials derived from the human body in order to provide an assessment of the person’s health, information for diagnosis, and treatment or prevention of any impairment or disease. Any company performing a test for these set of purposes are considered by CLIA to be a laboratory, and must abide by CLIA regulations by registering with the CLIA Program if they want to receive the benefits.

What are CPT Codes for CLIA-Waived Tests?

Click here to see a complete list- Note: this is only for informational purposes and may not accurately represent current CMS CPT Codes. Make sure to verify the status of your waived tests and CPT Code prior to implementing any testing. Drugs of Abuse (Use G0477QW for visually read devices or G0478QW for instrument read devices).

Why Customers Use Our Drug Test Cups?

99% Accuracy

Instant Results in 5-7 min

Easy To Use

CLIA-Waived & FDA Cleared

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