Generally, facilities that test and result samples in the United States for health assessments, diagnosis, prevention, or treatment are regulated under CLIA.
Waived tests are those cleared by the FDA for home use or approved for waiver under CLIA criteria.
This program supports a variety of organization types:
A new CLIA certificate is required. We’re ready to assist in securing this for you.
Our platform will simplify your compliance management if you obtain the certificate independently.
Registration, consent, resulting, and reporting software
Real-time data and dashboards customized for your organization
Account management
CLIA-waiver certificate
The knowledge you are helping to keep your community safe by providing these testing services!
Access to a call center to support participants
Tests under CDPH
Testing sites under CDPH
School districts under CDPH
Primary.Health is working to eliminate long-standing health and social inequities and disparities by empowering inclusivity and illuminating social determinants of health through not only our software, but on providing services where they are needed most, including communities of color, unhoused populations, institutional settings–wherever people are.
We’re here to help you navigate the CLIA Waiver application process and support your program.
Still have questions? Contact us