SalivaDirect: Lab authorization request form
SalivaDirect received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) on August 15th, 2020, for the detection of nucleic acid from SARS-CoV-2 only.
The SalivaDirect EUA is for a Laboratory Developed Test, but we have the right to designate other labs.
Only high complexity CLIA-certified labs in the United States can become designated to run SalivaDirect. Please fill out this form if you would like to receive more information on how to become a designated lab. Only one lab site may apply at a time.