binx health At-Home Nasal Swab COVID-19 Sample Collection Kits

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• The Self-Collection Kits have not been FDA cleared or approved but have been authorized for emergency use by FDA under an emergency use authorization for use by Authorized Laboratories. "Authorized Laboratories" means laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests and that run the specimens collected from the Self-Collection Kits on an in vitro diagnostic (IVD) molecular test that is indicated for use with the Self-Collection Kits.
• Emergency use of these Self-Collection Kits 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 in vitro diagnostics 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 Self-Collection Kits have been authorized only for the self-collection and maintenance of nasal swab specimens as an aid in the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.