Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in North Carolina
- The Division says even a finger-stick glucose or a urine dip requires a CLIA certificate, and each separate physical testing location needs its own CLIA number.
- Send no money with the application; CMS bills the certificate fee after the State Agency enters it.
Does North Carolina require a state lab license on top of CLIA?
North Carolina follows the CLIA regulations and has no separate state licensure for laboratories or laboratory personnel. A waived site needs only its CLIA Certificate of Waiver.
- Does not reach waived-only labs
Where does a North Carolina CMS-116 go?
- North Carolina Department of Health and Human Services, Division of Health Service Regulation, CLIA Certification
- Email: DHSR.CLIA@dhhs.nc.gov
- Phone: (919) 855-4620
Opening a testing site in North Carolina?
We prepare the CMS-116 and any North Carolina 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.