COVID-19 Test Kits

**Fact Sheet:https://www.fda.gov/media/141195/download‍

**Disclaimer: This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; • This product has been authorized only for the 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; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices 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.

**IFU: /https://www.fda.gov/media/145931/download

**Fact Sheet: /https://www.fda.gov/media/145930/download

**Disclaimer: This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens; and • The emergency use of this 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 COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

**IFU: /https://www.fda.gov/media/136112/download

**Fact Sheet:https://www.fda.gov/media/136111/download

‍**Disclaimer: This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this 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 COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbbPage 10 – Ian McGill, Thermo Fisher Scientific, Inc. 3(b)(1), unless the declaration is terminated or the authorization is revoked sooner.

**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.

**IFU:https://www.fda.gov/media/136355/download

**Fact Sheet:https://www.fda.gov/media/136349/download

‍**Disclaimer: This test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this 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 declaration is terminated or authorization is revoked sooner.

**IFU:/https://www.fda.gov/media/144574/download

**Fact Sheet: https://www.fda.gov/media/147253/download

**Disclaimer: This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories.This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens. This 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 COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner. 

**IFU: https://www.fda.gov/media/147694/download

**Fact Sheet: /https://www.fda.gov/media/147693/download

‍**Disclaimer: This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; • This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, • The emergency use of this 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 COVID-19 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.

**IFU:https://www.tga.gov.au/sites/default/files/covid-19-rapid-antigen-self-tests-are-approved-australia-ifu-342512.pdf

**Fact Sheet: https://www.fda.gov/media/142918/download

‍**Disclaimer: This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens. This 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 COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner

** IFU: https://www.fda.gov/media/152699/download

**Fact Sheet: https://www.fda.gov/media/152697/download

‍**Disclaimer: This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens. This 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 COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.