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Respiratory Test Kit BD Veritor System SARS-CoV-2 30 Tests CLIA Waived

BEC 256082
VERITOR SARS-COV-2 RAPID TEST
UOM : BX (30 EA)
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BD Veritor System
BEC 256082

About this product

Item #: 256082

30 TESTS/KIT
EXPIRATION DATING – 6 MONTHS FROM DATE OF MANUFACTURE


Highlights

Veritor™ System for Rapid Detection of SARS-CoV-2, 30 tests/kit (12 kt/plt) (Orders are Non-Cancellable; Item is Non-Returnable) (60 Days Dating)

  • 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/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
  • 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
  • Product ships with minimum 60 days dating
  • 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

Item Specifications

  • Respiratory Test Kit
  • BD Veritor System
  • CLIA Waived
  • (30) Single-use Test Devices, (30) Single-use Reaction Tubes, (30) Sterile Single-use Specimen Sampling Swabs, Positive SARS-CoV-2 Control Swab, Negative SARS-CoV-2 Control Swab, Instructions for Use, Quick Reference Card, Nasal Sampling Instructions
  • China
  • For use with the BD Veritor Plus Analyzer running Firmware version 5.4 or later
  • BD
  • 256082
  • 30 Tests
  • Standard Purchase
  • Machine Read
  • Nasal Swab Sample
  • Immunoassay
  • Test Device Format
  • Rapid
  • Chromatographic Digital Immunoassay
  • SARS-CoV-2
  • Infectious Disease Immunoassay
  • 15 Minute Results
  • 41116144