Product Overview Product feature summary

• This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; LI>

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

• 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.

Specifications Product specifications and dimensions

• Additional Attributes
  OTC SELF TESTING
• Brand
  BinaxNOW
• CLIA Classification
  CLIA Exempt
• Item
  Antigen Self Test
• Item Type
  COVID-19 Antigen
• Secondary Size
  2 Test/Kit

Catalog Description As seen in our print catalog

A lateral-flow immunochromatographic assay for the detection of nucleocapsid protein antigens specific to SARS-CoV-2. Uses anterior nasal swab specimens self collected by individiuals 15 or older or collected by an adult from an individual aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first seven days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for indivudals without symptoms or other epidemiological reasons to suspect COVID-19, when tested three times over five days with at least 48 hours between tests.