If you require additional guidance, please contact your Local State or County Health Agency to ask for about using devices under emergency use authorization.
You can also review these links that might be helpful:
Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states.
Please review the product insert regarding what type of blood sample will be appropriate to use in your test.
Who can buy these tests?
Medical providers such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings that have appropriately trained personnel or medical supply distribution companies that currently sell medical products to these settings.
Is my test setting moderate- or high-complexity?
CLIA (The Clinical Laboratory Improvement Amendments) has established quality standards for all lab testing to ensure the accuracy, reliability, and timeliness of patient test results. Under CLIA, a lab is any facility that tests human specimens for a health assessment or to diagnose, prevent, or treat disease. Facilities that meet this definition must obtain CLIA certification to operate legally.