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CLIA waived drug test kits

Quality CLIA waived drug test kits.

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What Is CLIA?

CLIA stands for ‘Clinical Laboratory Improvement Amendments.’ This amendment specified that laboratory requirements must be based on the complexity of the test performed. As a result they established provisions for categorizing a test as Waived.

If a test meets the requirements set by this statute, then they may be waived from regulatory oversight. Waived tests were defined as simple laboratory procedures that are cleared by the FDA for home use and that incorporate methodologies that are so easy and accurate that it is unlikely that mistakes would occur. Another requirement is that they would pose no reasonable risk of harm to a patient if they were performed incorrectly.

Do I Need A CLIA-Waived Test?

CLIA requirements do apply to entities that perform tests on ‘materials derived from the human body for the purpose of providing information for diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings’ to meet certain Federal requirements. If the tests are performed for these purposes, the organization doing so is considered under CLIA to be a laboratory and must register with the CLIA program. In these instances, the advantage of using a CLIA Waived test is that it waives you from having to comply with a long list of laboratory requirements (such as quality control, training, etc).

CLIA-Waived tests can still be used for use in the workplace and at home as Waived product. They are simple to use and have a FDA 510(k) clearance.

The cost of a CLIA waived test can be claimed back through Medicaid and Medicare. Refer to the CMS website.

When drug testing with dip cards use a Specimen Container and Drug Adulteration Test Strip.

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