Product Overview Product feature summary

• This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under CLIA that meet the requirements to perform moderate, high or waived complexity tests.

• This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

• This product has been authorized only for the detection of proteins 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.LI>

Specifications Product specifications and dimensions

• Brand
  Status
• CLIA Classification
  CLIA Waived
• Item
  Test Kit
• Item Type
  COVID-19/Flu A&B
• Quantity
  25/Box

Catalog Description As seen in our print catalog

A lateral flow immunoassay for the rapid, simultaneous qualitative direct detection and differentiation of nucleocapsid antigen from SARS-CoV-2, as well as influenza type A and type B, directly from anterior nasal or nasopharyngeal swab specimens. The test is authorized for use on specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms.