State filing guide
CLIA waiver application and requirements in Illinois.
Ask about my application — no payment todayIllinois explicitly identifies CMS-116 for a waived-only application.
Sources checked 2026-09-10 · next source check due 2026-10-10
Federal application procedure
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
- IDPH's FAQ says waived-only applicants submit CMS-116.
- Home-health applicants must also provide a copy of their license; that is a separate facility-specific requirement.
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 that this is a fixed clinical site rather than a home-health or health-screening arrangement.
Frequently asked questions
What filing route does the cited Illinois guidance describe?
Illinois explicitly identifies CMS-116 for a waived-only application.
Which requirements are named in the cited Illinois materials?
IDPH's FAQ says waived-only applicants submit CMS-116. Home-health applicants must also provide a copy of their license; that is a separate facility-specific requirement.
What do the sources establish about fees and timing in Illinois?
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 Illinois?
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.
Official sources behind this guide
Need help with your Illinois CLIA route?
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From test research to your Illinois 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.