Rheonix Laboratories is a New York State permitted CLIA laboratory that provides PCR COVID-19 testing and results.

This self-collection kit has not been FDA cleared or approved but has been authorized for emergency use by the FDA under and EUA for use by authorized laboratories.  Specimens collected with this self-collection kit must be analyzed using the Rheonix COVID-19^TM MDx Assay.  This self-collection kit has been authorized only for the self-collection and maintenance of saliva specimens as an aid in the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.   The emergency use of this self-collection kit in  combination with the authorized test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices 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.