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For use with the BD Veritor™ System for Rapid Detection of SARS-CoV-2 Assay as External Quality Control Materials
Levels
Positive Level / Negative Level
Test Name
SARS-CoV-2
UNSPSC Code
41116145
Features
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 product is only for use under Emergency Use Authorization in 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 and 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
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 shoul d 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
Includes: 10 SARS CoV-2 Negative Control Swabs
10 SARS CoV-2 Positive Control Swabs
and Instructions for use
SWAB SET, CONTROL SARS-COV-2 BD VERITOR SYSTEM (10/KT)
