The Lucira CHECK-IT COVID-19 Test Kit is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is authorized for nonprescription over-the-counter (OTC) use with self-collected nasal swab samples in individuals 14 years and older (self-collected) or individuals ≥2 years (collected by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19.

The Lucira CHECK-IT COVID-19 Test Kit is for use only under the Food and Drug Administration’s Emergency Use Authorization.

This Lucira CHECK-IT COVID-19 Test Kit contains everything needed to perform one (1) Lucira COVID-19 test: Instructions, 2 AA Batteries, 1 test unit, 1 sample vial, 1 sterile nasal swab and 1 disposal bag. For this test to work properly, it is important to read the instructions and follow each step.

EUA Disclaimer: Lucira CHECK-IT COVID-19 Test Kit has not been FDA cleared or approved but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA).  It 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.  This authorization is 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 revoked sooner.

The Lucira COVID-19 All-In-One Test Kit is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is authorized for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider. This test is also authorized for use at the Point of Care (POC), in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, for individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider at the POC. This test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA in individuals with known or suspected COVID-19.

The Lucira COVID-19 All-In-One Test Kit is for use under the Food and Drug Administration’s Emergency Use Authorization only.

This Lucira COVID-19 All-In-One Test Kit contains everything needed to perform one (1) Lucira COVID-19 test: Instructions, 2 AA Batteries, 1 test unit, 1 sample vial, 1 sterile nasal swab and 1 disposal bag. For this test to work properly, it is important to read the instructions and follow each step.

EUA Disclaimer: Lucira COVID-19 All-In-One Test Kit has not been FDA cleared or approved but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA).  It 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.  This authorization is 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 revoked sooner.

The Lucira COVID-19 & Flu Home Test is a single use (disposable) home test kit intended for simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral nucleic acid. This test is authorized for non-prescription home use with anterior nasal swab samples from individuals 14 years or older (self-collected) or individuals 2 years or older (collected by an adult) with signs and symptoms consistent with a respiratory tract infection, including COVID-19.

The Lucira COVID-19 & Flu Home Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

This Lucira COVID-19 & Flu Home Test contains everything needed to perform one (1) Lucira COVID-19 & Flu Home Test: Instructions, 2 AA Batteries, 1 test unit, 1 sample vial, 1 sterile nasal swab and 1 disposal bag. For this test to work properly, it is important to read the instructions and follow each step.

EUA Disclaimer: Lucira COVID-19 & Flu Home Test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA).  It has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens.  This authorization is 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.

The Lucira COVID-19 & Flu Test is a single use (disposable) RT-LAMP test kit intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B viral RNA in anterior nasal swab specimens collected from individuals (2 years of age or older) who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. The Lucira COVID-19 & Flu Test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The Lucira COVID-19 & Flu Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

This Lucira COVID-19 & Flu Test contains everything needed to perform one (1) Lucira COVID-19 & Flu Test: Instructions, 2 AA Batteries, 1 test unit, 1 sample vial, 1 sterile nasal swab and 1 disposal bag. For this test to work properly, it is important to read the instructions and follow each step.

EUA Disclaimer: Lucira COVID-19 & Flu Test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA).  It has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens.  This authorization is 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.