Product Overview Product feature summary

• • This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.
• • 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Specifications Product specifications and dimensions

• Brand
  Metrix
• CLIA Classification
  CLIA Waived
• Item
  Starter Bundle
• Item Type
  COVID-19/Flu A&B
• Quantity
  Each
• With
  50 Tests and 1 reader