Product Overview Product feature summary

• • This Test Has An Emergency Use Authorization (EUA) From FDA, But It Has Not Been FDA Cleared Or Approved.


• • Testing of nasopharyngeal swab, anterior nasal swab or nasal wash/aspirate specimens run on the GeneXpert Dx and GeneXpert Infinity Systems is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high or moderate complexity tests.


• • Testing of nasopharyngeal or anterior nasal swab specimens run on the GeneXpert Xpress System (Table and Hub Configurations) 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 and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Specifications Product specifications and dimensions

• Brand
  Xpert Xpress
• CLIA Classification
  CLIA Waived
• Item
  Test Kit
• Item Type
  Sars-CoV-2/Flu/RSV Plus
• Quantity
  10/Box

Catalog Description As seen in our print catalog

Artist: Please move the following copy to the beginning of the Note field, directly below the last item code, and remove the italics. Copy won't fit into field in Stibo:
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.