How does that affect this test? In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A, and influenza B, 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 authorization is revoked sooner.

No, you do not need insurance to use this test. The Flowflex Plus COVID-19 and Flu A/B Home Test is for over-the-counter (OTC) use.

Yes, this test is an eligible expense that can be reimbursed under FSAs.

We are continuously monitoring the arrival of new COVID-19 variants, and we promptly evaluate our test’s performance against any new variants, as clinical samples containing the new variants become available to us. This process takes time, but as soon as the results are in, we issue a Press Release on our website to keep consumers informed in a timely manner.