Product Overview Product feature summary

• • This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.
• • This product has been authorized only for the detection and differentiation of nucleic acid 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
• • This test is authorized for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B viral RNA in anterior nasal swab specimens collected from individuals (2 years of age or older) who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider.

Specifications Product specifications and dimensions

• Brand
  Lucira
• CLIA Classification
  EUA
• Item
  Test Kit
• Item Type
  COVID-19/Flu A&B
• Quantity
  Each

Catalog Description As seen in our print catalog

A single-use combined COVID-19, Flu A, and Flu B testing device for fast, accurate, point-of-care testing powered by molecular technology. For ages 2 and up.