U2 Regulatory

The links below contain foundational information and resources, to help you set up your COVID-19 diagnostic testing program.

Knowing where to look for the latest information can be daunting, and time consuming. Below are some useful links to help you navigate the most up-to-date Federal guidance for COVID-19 (SARS-CoV-2) testing:

For help preparing for flu season, below are some useful links to help you navigate the most up-to-date Federal guidance for Flu A + B testing

Some diagnostic testing may be CLIA-waived, and include BD Veritor^TM Plus System rapid antigen testing for SARS-CoV-2*, Flu A+B, Group A Strep and RSV.

BD Veritor™ Plus System tests can only be used in labs that are CLIA certified. A ‘lab’ refers to a facility that performs diagnostic tests from samples collected from the body. Naturally, that includes hospitals and clinical laboratories but also can include pharmacies, schools, long-term care facilities, and some businesses. These non-traditional locations can use the BD Veritor™ System tests and other simple CLIA-waived tests if they apply and are granted a CLIA certificate of Waiver. These non-traditional facilities can apply for a CLIA Certificate of Waiver at www.cms.gov

A Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver allows the lab to perform tests that have been granted CLIA waived status by the US FDA in order to help assess health, diagnose and determine treatment.

For COVID-19 specifically, testing is limited to laboratories certified under CLIA that meet the requirements to perform high, moderate, or waived complexity tests during the COVID-19 emergency.