Vitas is a European analytical laboratory, operating under Norwegian and EU regulatory frameworks (IVDR 2017/746).
Vitas does not hold a CLIA certificate or a California Out-of-State Clinical Laboratory License, as these are only required for laboratories performing clinical testing on human samples collected in the U.S. and used for diagnosis, prevention, or treatment of disease.
The analyses performed by Vitas on behalf of Zinzino are defined as non-clinical, wellness, and lifestyle guidance tests.
These tests are not used for medical decision-making or diagnosis, and results are intended for general lifestyle awareness.
According to both U.S. federal and California state law, CLIA and California licensing requirements apply only when results are used for medical purposes.
Therefore:
- CLIA does not apply to Vitas as the laboratory is based in the EU and the tests are not of clinical nature.
- California state licensing is likewise not required for lifestyle or wellness-oriented testing, provided the reports clearly state that results are not for clinical use and not intended to diagnose or treat any disease.
- Responsibility for regulatory compliance in each market, including how tests are marketed and interpreted, rests with the entity distributing or selling the test—in this case, Zinzino.
To remain compliant, it is essential that the test reports and marketing materials consistently communicate that the analyses are for informational and lifestyle purposes only.