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SLI MEDICAL IS A WHOLESALE SITE! WE ONLY SELL TO QUALIFIED FACILITIES (Such As Hospitals, Physician Offices, & Distributors). All Addresses are Verified.
For use with the BD Veritor™ Plus Analyzer running Firmware version 5.4 or later
Test Format
30 Tests
Test Kit Type
SLI Medical Acceptable Dating: we will ship >= 30 days
Test Method
Machine Read
Test Name
Nasal Swab Sample
Test Type
Test Device Format
Time to Results
Chromatographic Digital
UNSPSC Code
SARS-CoV-2
Infectious Disease Immunoassay
15 Minute Results
41116144
Features
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
Product ships with minimum 60 days dating
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
TEST KIT, SARS-COV-2 BD VERITOR RAPID DETECT (30TEST/KT)
