Control Set BD Veritor™ SARS-CoV-2 Positive Level / Negative Level

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

More Information

• BD Veritor System SARS-CoV-2 Rapid Detection FDA EUA Letter
• BD Veritor SARS-CoV-2 Control Swab Set IFU
• BD Veritor System SARS-CoV-2 Rapid Test Healthcare Providers Fact Sheet
• BD Veritor System SARS-CoV-2 Rapid Detection Patients Fact Sheet