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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner

Specifications Product specifications and dimensions

• Brand
  Visby Medical
• CLIA Classification
  EUA
• Item
  Promo Pack
• Item Type
  Respiratory Health Test
• Quantity
  Each
• With
  1 Case of Respiratory Health Tests (20 tests)/2 Visby Power Adapters/1 Respiratory Control Kit (2 Pos/2 Neg)