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

Tests for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset. The test can also be used by individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. This test has been authorized for non-prescription use with self-collected specimens from individuals age 14 and older or with adult collected specimens from individuals 2 years or older. One test only required. No serial testing needed.