CLIA Waived Tests
|The FDA policy specified that CLIA waived tests are the simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.
Now the CLIA waiver requirements are corrected and this is clear that test devices approved for home use by the Food and Drug Administration mechanically become the CLIA waived tests. Professional use versions of home use tests are not automatically waived. On the other hand, professional edition of such test kits do become qualified for simple waiver evaluation if the only differences between tests versions need to be studied to conclude whether the professional version qualifies for waiver.|
Medimpex United Inc. and its affiliates, partners, owners, employees, and suppliers cannot be held responsible for how customers use the products and services available through this website or other affiliate or linked websites. This product is not intended to diagnose, treat, cure, or prevent any disease.
We are not responsible for any damages or liabilities connected to use of any products purchased from Medimpex United Inc. By placing an order at check-out, you accept the terms of this disclaimer and agree to hold Medimpex United Inc. free of liability, expense, or loss.
All drug test products are intended for preliminary screening purposes. We strongly recommended that accredited laboratory testing is utilized to determine any positive test result. Medimpex United Inc. provides laboratory confirmation services such as these, as well.
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