Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Delaware
- Delaware wants certificate changes in writing with the CLIA number, signed by a person authorized to make changes.
Does Delaware require a state lab license on top of CLIA?
Delaware's CLIA program answers that "the State of Delaware only follows CLIA guidelines" and that "there are no additional requirements unique to Delaware," in reply to a waived screening program asking about state paperwork.
- Does not reach waived-only labs
What does Delaware charge?
No state laboratory fee; the lab pays only the CMS certificate fee.
Do labs in other states need a Delaware 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 Delaware CMS-116 go?
- Delaware State Public Health Laboratory
- Email: CLIA.delaware@delaware.gov
- Phone: (302) 802-5000
Opening a testing site in Delaware?
We prepare the CMS-116 and any Delaware 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.