**IFU (Check-IT):https://www.fda.gov/media/147494/download
** Fact Sheet (Check-IT):: https://www.fda.gov/media/147493/download
**FAQ: https://www.lucirahealth.com/wp-content/uploads/2021/03/Package-Insert-PI-INST017-Rev-1.64.pdf
**Disclaimer: This OTC test kit (or product) has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA. This OTC test kit (or product) has been authorized only for the testing of nasal swabs for detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this OTC test kit (or product) 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 COVID19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
