Product Overview Product feature summary

• • This Test Has Not Been FDA Cleared Or Approved;


• • This Item Is Authorized By FDA Under An Emergency Use Authorization ("EUA"), And Performance Of This Test Is Limited To Authorized Laboratories Using The BD Veritor Plus Analyzer Instrument. Authorized Laboratories Means Laboratories Certified Under The Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42 U.S.C. õ263a, That Meet The Requirements To Perform High, Moderate, 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 Test Has Been Authorized Only For The Detection Of Proteins From SARS-CoV-2, Not For Any Other Viruses Or Pathogens; And


• • This Test Is Only Authorized For The Duration Of The Declaration That Circumstances Exist Justifying The Authorization Of Emergency Use Of In Vitro Diagnostic Tests For Detection And/or Diagnosis Of COVID-19 Under Section 564(b)(1) Of The Act, 21 U.S.C. õ360bbb-3(b)(1), Unless The Authorization Is Terminated Or Revoked Sooner.

Specifications Product specifications and dimensions

• Brand
  BD Veritor
• CLIA Classification
  CLIA Waived
• For
  BD Veritor Reader
• Item
  Test Kit
• Item Type
  Sars-CoV-2

Catalog Description As seen in our print catalog

Point-of-care testing for SARS-CoV-2, Flu A+B, RSV (respiratory syncytial virus), and Group A Strep, providing rapid diagnostic testing in a convenient, portable instrument. One-button functionality and workflow flexibility allow the health-care team to confidently use the device. In addition, the system’s fast and reliable results may help improve the patient experience. The system streamlines the point-of-care testing experience, stores or downloads the lot number, patient/specimen ID, operator ID, and test records using the BD Veritor™ InfoWiFi module or via the companion ImageMover application.