Rapid Test Kit BD Veritor™ System Infectious Disease Immunoassay SARS-CoV-2 Nasal Swab Sample 30 Tests

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

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

In the United States, the BD Veritor™ System for Rapid Detection of SARS-CoV-2 is only for use under the Food and Drug Administration’s Emergency Use Authorization