BD Primary Care #256082 Rapid Test Kit BD Veritor™ System Infectious Disease Immunoassay SARS-CoV-2 Nasal Swab Sample 30 Tests TEST KIT, SARS-COV-2 BD VERITOR RAPID DETECT (30TEST/KT) Product ships from Rally with minimum 30 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 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 Manufacturer # 256082 Brand BD Veritor™ System Manufacturer BD Primary Care Country of Origin Unknown Application Rapid Test Kit Contents (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 For Use With For use with the BD Veritor™ Plus Analyzer running Firmware version 5.4 or later Number of Tests 30 Tests Product Dating Acceptable Dating: we will ship >= 30 days Reading Type Machine Read Sample Type Nasal Swab Sample Storage Requirements USP Controlled Room Temperature Test Format Test Device Test Method Chromatographic Digital Test Name SARS-CoV-2 Test Type Infectious Disease Immunoassay Time To Results 15 Minute Results UNSPSC Code 41116144 The BD Veritor System for Rapid Detection of SARS-CoV-2 is a chromatographic immunoassay for the direct and qualitative detection of SARS-CoV-2 antigens in nasal swabs from patients with signs and symptoms who are suspected of COVID-19. The BD Veritor™ System for Rapid Detection of SARS-CoV-2 adapts easily to your workflow by offering 2 operational modes Walk Away: The SARS-CoV-2 test device is inserted immediately after sample processing and addition into the Veritor Plus Analyzer, enabling staff to multitask while sample incubates Analyze Now: The SARS-CoV-2 test device is inserted after incubation time is complete, allowing batches of samples to be tested. FDA Disclaimers: This test has not been FDA cleared or approved; This test has been authorized by FDA under an EUA for use by authorized laboratories; This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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