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State filing guide

CLIA waiver application and requirements in Washington.

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Washington's Medical Test Site process integrates CLIA authorization.

Sources checked 2026-09-10 · next source check due 2026-10-10

State authorization required

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

  • Applicants use the state MTS route; the license includes the CLIA number.
  • Do not submit a duplicate separate federal CMS-116 application or assume an additional federal fee for this state process.

Fees and timing

Check the current MTS fee period. The state process integrates CLIA authorization; do not add a separate federal application fee by default.

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What still needs confirmation for your facility

  1. 1Confirm the waived MTS category, current application, fee period and exact test list.

Frequently asked questions

What filing route does the cited Washington guidance describe?

Washington's Medical Test Site process integrates CLIA authorization.

Which requirements are named in the cited Washington materials?

Applicants use the state MTS route; the license includes the CLIA number. Do not submit a duplicate separate federal CMS-116 application or assume an additional federal fee for this state process.

What do the sources establish about fees and timing in Washington?

Check the current MTS fee period. The state process integrates CLIA authorization; do not add a separate federal application fee by default.

Does this page confirm CLIA approval or legal compliance in Washington?

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 Washington CLIA route?

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From test research to your Washington 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.