Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
Does Colorado require a state lab license on top of CLIA?
CDPHE's CLIA page says clinical labs are registered through the federal CLIA certification program, with CMS-116 applications and changes emailed to CDPHE. No separate state laboratory license is described.
- Does not reach waived-only labs
What does Colorado charge?
No state laboratory fee; the lab pays only the CMS certificate fee.
Do labs in other states need a Colorado license to test its specimens?
No state laboratory license was found, so a lab in another state needs nothing from this state to test its specimens beyond its own CLIA certificate.
Where does a Colorado CMS-116 go?
- Colorado Department of Public Health and Environment, Laboratory Services Division
- Email: cdphe_cliaprogram@state.co.us
- Phone: (303) 692-3681
Opening a testing site in Colorado?
We prepare the CMS-116 and any Colorado filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.