This test has been authorized by the FDA under an Emergency Use Authorization for use by authorized laboratories. This test has not been FDA cleared or approved. This 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.
The First FDA Emergency Use Authorized
At-Home Saliva COVID-19 Test
Our self-collection testing kit for COVID-19 uses a hassle-free saliva sample to determine if your patients are infected with the SARS-CoV-2 virus. We’ve partnered with RUCDR Infinite Biologics lab operating under the Emergency Use Authorization guidelines issued by the FDA. Our test kits include a complimentary priority return mailer for sending the sample to the lab. Within 72 hours of the lab receiving the sample, you will be faxed the result and the patient can access the result in their dashboard. If the result is positive, it is reported to appropriate authorities.
Saliva Collection Tube
Digital Results Available Within:
72 hours of the lab receiving the sample
FDA Emergency Use Authorization:
FDA Fact Sheet: