The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older.

The BinaxNOW™ COVID-19 tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. They have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are 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. For serial testing, the BinaxNOW COVID-19 Antigen Tests should be performed twice over 3 days, at least 24 hours (and no more than 48 hours) apart. For symptomatic use, a single test can be used.

PANBIO COVID-19 ANTIGEN SELF TEST

The Panbio COVID-19 Self-Test is not approved for use in the US.

Panbio COVID-19/Flu A&B Rapid Panel test

The Panbio COVID-19/Flu A&B Rapid Panel test is a professional use test and is not approved for use in the US.

ID NOW COVID-19 Test

The ID NOW™ COVID-19 product has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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.

Alinity m Resp-4-Plex:

The Alinity m Resp-4-Plex is an Rx Only, In Vitro Diagnostic Use Device Under the FDA Emergency Use Authorization. This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet requirements to perform moderate or high complexity tests. This product has been authorized by FDA under an EUA for use by authorized laboratories certified under CLIA to perform moderate or high complexity tests. This product has been authorized only for the detection and differentiation of nucleic acid from influenza A, influenza B, Respiratory Syncytial Virus and 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. § 360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked sooner.