RAPID TEST KIT, SARS-COV-2 & FLU A&B (30TEST)

Shipments expected to begin around Sept 1, 2021 – Product ships with minimum 30 days dating
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 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-2thorized 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
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 Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests
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

Product Specification Sheet