BD Veritor System for Rapid Detection of SARS-CoV-2

BD

BD Veritor System for Rapid Detection of SARS-CoV-2

BD
SKU: 559995
MFG Part #: 256082
  • Rapid detection of SARS-CoV-2
  • Results are analyzed and digitally displayed by the BD Veritor Analyzer
  • Fast results in 15 minutes
  • Advanced particle technology for enhanced sensitivity
  • Authorized by the FDA under an EUA, pending FDA clearance / approval
    Notice

    To run a full test, you will need the Analyzer and Upgrade Key.

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    Price:
    $692.50 30 Tests / Kit

    Description

    The BD Veritor System for Rapid Detection of SARS-CoV-2 is a chromatographic immunoassay for the direct and qualitative detection of SARS-CoV-2 antigens in nasal swabs from patients with signs and symptoms who are suspected of COVID-19.

    Features

    • The BD Veritor™ System for Rapid Detection of SARS-CoV-2 is for use under an Emergency Use Authorization ONLY: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
    • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, 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
    • Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
    • Positive results do not rule out bacterial infection or co-infection with other viruses
    • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
    • Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
    • Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management
    • The BD Veritor System for Rapid Detection of SARS-CoV-2 is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings
    • BD Veritor™ System for Rapid Detection of SARS-CoV-2 is a chromatographic digital immunoassay intended for the direct and qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swabs from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms

    Product Specifications and Resources

    Number of Tests 30 Tests
    Reading Type Machine Read
    Sample Type Nasal Swab Sample
    Storage Requirements USP Controlled Room Temperature
    Test Format Test Device
    Test Method Chromatographic Digital
    Test Name SARS-CoV-2
    Test Type Infectious Disease Immunoassay
    Time to Results 15 Minute Results
    UNSPSC Code 41116144
    What's in the Box
  • 30x single use test devices
  • 30x single use reaction tubes, each with 325 µL extraction reagent and an integral dispensing tip
  • 30x sterile, single use specimen sampling swabs
  • 1x SARS-CoV-2 (+) control swab for single use
  • 1x SARS-CoV-2 (-) control swab for single use
  • Instructions for use
    Documents & Resources

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