No. A CLIA certificate, including the Certificate of Waiver, covers performing lab tests, not selling them. If your business sells tests that a CLIA-certified lab such as Labcorp performs, the lab holds the certificate and you don’t need one. You need your own only if you run tests on site, such as a finger-stick cholesterol or A1c analyzer.
This guide is for gym owners, coaches, med spas, chiropractors and wellness brands who want to sell lab testing and keep hearing that they need “a CLIA waiver.” It explains what CLIA covers, the line between selling and performing a test, when on-site testing changes the answer, how state lab licensing fits in, and the ordering rule that applies either way. For the full business setup, see how to start a lab testing business.
What Does a CLIA Certificate Cover?
A CLIA certificate covers a facility that tests human specimens. CLIA, the Clinical Laboratory Improvement Amendments of 1988, is the federal quality program for clinical labs. CMS runs certification, with CDC and the FDA supporting the program. CDC describes CLIA as setting “federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment” (CDC).
The trigger is testing. CMS puts it this way: “If a facility performs even one test on human samples to assess health or to diagnose, prevent, or treat any disease, it’s considered a laboratory under CLIA and must apply for and get a CLIA certificate” (CMS).
CMS issues five certificate types, and the one a lab needs depends on the most complex test it runs:
| Certificate | Who it’s for |
|---|---|
| Certificate of Waiver (CoW) | A lab that performs only waived tests |
| Certificate for Provider-performed Microscopy (PPM) | A lab where a physician, midlevel practitioner or dentist performs specific microscopy procedures during a patient visit |
| Certificate of Registration (CoR) | A temporary certificate that lets a lab run moderate and high complexity tests until its first survey |
| Certificate of Compliance (CoC) | A lab running moderate and high complexity tests that has passed a State Agency or CMS survey |
| Certificate of Accreditation (CoA) | A lab running moderate and high complexity tests that is accredited by a CMS-approved accreditation organization, such as CAP or COLA |
Source: CMS CLIA Certification guide. All certificate types are effective for two years, and the certificate fee recurs every two years.
A “CLIA waiver” is shorthand for the Certificate of Waiver. It is the lightest certificate, but it is still a lab certificate. It lets a site run waived tests, nothing more.
Do You Need a CLIA Certificate If You Only Sell Lab Tests?
No, as long as your business doesn’t perform the tests. The federal definition of a laboratory is a facility for the “examination of materials derived from the human body” to provide health information. The same definition then excludes the businesses that sit around the lab: “Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories” (42 CFR 493.2).
So in the most common white label setup, the CLIA obligations land on the lab, not on you:
- Your customer buys a test or panel under your brand.
- A licensed provider orders the test.
- The customer gives a sample at a Labcorp patient service center, or with an at-home kit that goes back to the lab.
- Labcorp runs the test and reports the result.
Labcorp states that it “is certified by CLIA” and “holds current licensure or permits required by state or local regulations” (Labcorp). Your business is the seller and the brand. It never touches the analyzer.
The same reasoning generally applies to at-home kits. Shipping a kit to a customer and having the sample returned to a certified lab is collection and mailing, which the definition excludes. The lab that runs the kit is the one that needs the certificate. Our guide to at-home blood collection covers the collection options in more detail.
When Would Your Business Need Its Own CLIA Certificate?
You need one the moment your business produces a test result on site. Common examples for wellness businesses:
- Finger-stick analyzers. A gym, med spa or chiropractic office that runs a point-of-care cholesterol, glucose or A1c test and reads the result on the spot is performing testing.
- Screening events. A health fair or member screening day where staff run finger-stick tests is still testing. CMS lets mobile units, health screening fairs and other temporary testing sites be covered under the certificate of a designated primary site, but they still need to be covered (CMS).
- Rapid tests run by staff. Any rapid test your team performs and reads for a client counts, even if it is simple.
Two limits catch people out.
A Certificate of Waiver only covers waived tests. Waived tests are, in CMS’s words, “simple tests with a low risk of an incorrect result,” and the FDA decides which tests qualify. CDC adds that “waived tests include test systems cleared by the FDA for home use and those approved for waiver under the CLIA criteria” (CDC).
Many popular wellness markers are not waived. We checked the FDA’s list of currently waived analytes in November 2026 (FDA):
| Marker | On the FDA waived analytes list? |
|---|---|
| Cholesterol, HDL cholesterol, triglycerides | Yes |
| Glucose | Yes |
| Hemoglobin A1c | Yes |
| TSH | Yes |
| Testosterone | No |
| Vitamin D | No |
| PSA | No |
| Ferritin | No |
A marker appearing on the list means at least one test system for it is waived. It doesn’t mean every device that measures it is. Check the specific device in the FDA CLIA database before you buy it.
Tests that aren’t waived are moderate or high complexity under 42 CFR 493.5. CMS says labs running them “must have a CLIA certificate, be surveyed (inspected), and meet the quality standards outlined in the CLIA regulations.” That is a different business from selling tests. We cover what opening a lab involves in how to start a lab testing business.
How Do You Get a CLIA Certificate of Waiver?
If you do decide to run waived tests on site, CMS lays out the process (CMS):
- Complete Form CMS-116, the CLIA application.
- Submit it to your State Agency, in the state where your testing site is located.
- Receive a fee coupon with your 10-character CLIA number and pay the certificate fee on pay.gov.
- Receive your certificate by email and begin testing.
- Pay fees every two years to keep the certificate.
The regulation also says a lab “must file a separate application for each laboratory location,” with exceptions for mobile units and temporary sites (42 CFR 493.35). For waived testing, CMS says you “must have a CLIA certificate and follow the manufacturer’s instructions for the waived tests.” CMS also tells applicants to check with the State Agency for state-based requirements, which is where the next section comes in.
What About State Lab Licensing, Like New York?
Some states run their own lab licensing on top of, or in place of, CLIA. This matters in two ways: for a business that runs tests on site, and for the lab that runs your customers’ tests.
- New York. The Wadsworth Center’s Clinical Laboratory Evaluation Program says “Only laboratories that hold a New York State clinical laboratory permit are authorized to perform testing” on New York specimens, and that “any laboratory seeking to test New York State specimens must obtain CLEP approval” (Wadsworth Center). Sites that perform only waived tests or provider-performed microscopy, such as hospital-owned physician practices, nursing homes, school health services and “other direct patient care facilities,” register as Limited Service Laboratories. So a New York business running waived tests on site should expect a state registration on top of its CLIA certificate.
- New York and Washington. CMS notes that labs in these two states “may not need a CLIA certificate” because both states “operate their own HHS-approved laboratory regulatory programs,” and that New York’s exemption is partial (CMS).
- Other states. CMS tells every applicant to check with its State Agency because some states have additional state-based requirements. Check with your state health department before you run any test on site.
If you only sell tests, state lab licensing is mostly the lab’s job, but it still shapes where you can sell. Ordering rules in New York, New Jersey and Rhode Island are stricter than in most states, as our guide on who can order lab tests explains.
Who Has to Order the Test Either Way?
Someone authorized under state law. Not needing a CLIA certificate doesn’t make you the person who orders.
Under CLIA’s quality rules for nonwaived testing, a lab “must have a written or electronic request for patient testing from an authorized person” (42 CFR 493.1241). An authorized person is “an individual authorized under State law to order tests or receive test results, or both” (42 CFR 493.2). Who that is depends on the state. For a gym, coach or med spa selling testing to customers, it in practice means a licensed provider orders each test. Some states let consumers order certain tests for themselves; our guide to who can order lab tests covers which.
On Karpa, that is built in. A licensed provider in Karpa’s independent network orders every test, Labcorp performs it, and the result goes to the customer’s portal under your brand. Your business needs no medical license, no CLIA certificate and, for a labs-only brand, no LegitScript certification. Results are not reviewed by a provider by default; a provider looks at them only if the customer books a TRT or HRT consult.
Selling vs. Performing: A Quick Check
| What your business does | Own CLIA certificate needed? |
|---|---|
| Sells tests that a CLIA-certified lab performs, with an authorized person (usually a licensed provider) ordering | No |
| Ships at-home collection kits that go back to a certified lab | Generally no |
| Sends customers to a lab patient service center to give a sample | No |
| Draws or collects samples on site and sends them to a lab, without testing them | Generally no under the federal definition, but check state rules on specimen collection |
| Runs finger-stick or rapid tests on site and reads the result | Yes, at least a Certificate of Waiver, for waived tests only |
| Runs testosterone, vitamin D or other nonwaived tests on site | Yes, a Certificate of Compliance or Accreditation, with inspections and a qualified lab director |
The Bottom Line
You don’t need a CLIA waiver to sell lab tests that a certified lab performs. CLIA follows the testing, so the lab holds the certificate. You need your own certificate only if you run tests on site, and a waiver covers only FDA-waived tests. Either way, someone authorized under state law has to order each test, and for a business selling to customers that usually means a licensed provider.
To see how the model fits a training business, read blood testing for gyms. To compare providers, see the best white label lab testing companies. Or book a call to see a lab storefront under your brand.
