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VIS-256088 |

Respiratory Test Kit BD Veritor™ System SARS-CoV-2 / Influenza A + B 30 Tests CLIA Waived

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About this item

  • BD Veritor System for Rapid Detection of SARS-CoV-2 and Flu A+B is For use under an Emergency Use Authorization only: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnost
  • BD Triplex assay requires Veritor™ System firmware version 5.5 or greater; firmware version info is displayed on screen when turning on the analyzer or on the orange sticker if it is attached to the analyzer
  • Product ships with minimum 60 days dating
  • This test is authorized for use at the Point of Care (POC), i.e., i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditationtories certified under the Clinical Laboratory Im
  • 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
  • The test is intended to be used with direct nasal swabs and is not validated for use with swabs in viral transport media
  • Kit configured for testing anterior nasal swab samples freshly collected, processed, and dispensed directly onto assay test device
  • 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 SARS-CoV-2 results to the appropriate public health authorities
  • Negative results should be treated as presumptive, do not rule out either Influenza or SARS-CoV-2, 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 one of these infections
  • Negative results for SARS-CoV-2 should be confirmed with a molecular assay, if necessary, for patient management
  • The BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B is intended for use in point of care settings by trained healthcare professionals or other users specifically instructed in the use of BD Veritor Systems and proper infection control p
  • Time to result: 15 minutes, test device can be read at 15 minutes but no later than 20 minute
  • Price: Available Upon Quote

    50+ In Stock.

    RAPID TEST KIT, SARS-COV-2 & FLU A&B (30TESTS/KT)
    Product Specifications:
    Manufacturer #: 256088
    Brand: BD Veritor™ System
    Manufacturer: BD
    Country of Origin: United States
    Application: Respiratory Test Kit
    CLIA Classified: CLIA Waived
    Contents 1: (30) Single Use Test Devices, (30) Single Use Reaction Tubes with 400 µL Reagent, (30) Sterile Single Use Sampling Swabs, 1 Positive SARS-CoV-2 Control Swab, 1 Positive Flu A Control Swab, 1 Positive Flu B Control Swab, (3) Paperboard Tube Stands, IF
    For Use With: For use with the BD Veritor™ Plus Analyzer running Firmware version 5.50 or late
    HCPCS: U0003
    Number of Tests: 30 Tests
    Product Dating: McKesson Acceptable Dating: we will ship >= 60 days
    Purchase Program Type: Standard Purchase
    Reading Type: Machine Read
    Sample Type: Nasal Swab Sample
    Specialty: Immunoassay
    Test Format: Test Device Format
    Test Kit Type: Rapid
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