State filing guide
CLIA waiver application and requirements in Utah.
Ask about my application — no payment todayUtah lists ownership disclosure alongside the CMS-116 application.
Sources checked 2026-09-10 · next source check due 2026-10-10
Additional application documents
These findings describe the linked sources. They do not establish that your facility qualifies for an exemption or that its application is ready. Facility type, ownership, personnel, locations and exact test systems can change the requirements.
What the official sources say
- The state certification page provides CMS-116 and ownership/controlling-interest disclosure forms.
- A supplemental disclosure should be distinguished from a separate laboratory license.
Fees and timing
Check the current agency fee notice and fee schedule. Government fees are separate from preparation-service fees. This source summary does not promise a processing or approval date.
Check my test menuWhat still needs confirmation for your facility
- 1Confirm the current disclosure requirements, signatures and application destination.
Frequently asked questions
What filing route does the cited Utah guidance describe?
Utah lists ownership disclosure alongside the CMS-116 application.
Which requirements are named in the cited Utah materials?
The state certification page provides CMS-116 and ownership/controlling-interest disclosure forms. A supplemental disclosure should be distinguished from a separate laboratory license.
What do the sources establish about fees and timing in Utah?
Check the current agency fee notice and fee schedule. Government fees are separate from preparation-service fees. This source summary does not promise a processing or approval date.
Does this page confirm CLIA approval or legal compliance in Utah?
No. This is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device. Verify every requirement with CMS, the FDA, and your state agency before testing.
Other jurisdictions
Each jurisdiction publishes its own terminology, forms, channel, signatures, and fees.
All 52jurisdictions →Official sources behind this guide
Need help with your Utah CLIA route?
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From test research to your Utah application
An analyte label does not confirm a device. The exact test system and the clinic’s state route need separate review before a filing scope or price can be confirmed.