Product Overview Product feature summary

• This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for non-prescription use.

• This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,

• 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[1]3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Specifications Product specifications and dimensions

• Brand
  Flowflex
• CLIA Classification
  OTC
• Item
  COVID-19 Antigen
• Item Type
  Home Test
• Secondary Size
  Single Test

Catalog Description As seen in our print catalog

A lateral-flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. This test is authorized for nonprescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. Do not use on anyone under 2 years of age. Swab specimen should be processed and tested immediately after collection.