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

Features

• NEW ITEM - Shipments expected to begin around Sept 1, 2021
• 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
• BD Veritor Plus System SARS/Flu (Triplex) Combo Promotional Kit - 2 X (256088) SARS-CoV-2/Influenza A + B Rapid Test Kit and (256066) BD Veritor Plus Analyzer
• 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/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
• 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 Accreditation
• 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 product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens
• 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 procedures
• Time to result: 15 minutes, test device can be read at 15 minutes but no later than 20 minute
• Each test kit contains: (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, IFU, Quick Ref Card, and Nasal Sampling Guide

More Information

• BD Veritor System COVID-19 and Flu A+B FDA EUA Letter
• BD Veritor System COVID-19 and Flu A+B IFU
• BD Veritor System COVID-19 and Flu A+B Patients Fact Sheet
• BD Veritor System COVID-19 and Flu A+B Customer Letter April 2021
• BD Veritor System COVID-19 and Flu A+B Healthcare Providers Fact Sheet
• BD Veritor System COVID-19 and Flu A+B Sales Sheet