For clinical labs
Designation processInterested in becoming a designated lab?
SalivaDirect™ reagents & instruments
New instruments and reagents are added regularly.Read More
Qualified lots of reagentsList of qualified reagents and materials for testing.Read More
Designated lab portalVisit our secure portal, containing resources and documents for SalivaDirect™ Designated Labs.Read More
Important Regulatory Information about SalivaDirect™
SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.