Respiratory Test Kit Visby Medical™ COVID-19 / Influenza A + B 20 Tests CLIA Waived

Features

• The Visby Medical Respiratory Health Test is authorized for Emergency Use by FDA under an EUA for use by Authorized Labs: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
• Visby Medical Respiratory Health Test is a single-use (disposable), fully integrated, rapid, automated RT-PCR in vitro diagnostic test intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral RNA in healthcare provider-collected nasopharyngeal and anterior nasal swab specimens, and healthcare provider-instructed self-collected anterior nasal swab specimens (collected on site) from individuals with signs and symptoms of respiratory tract infection consistent with COVID-19
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests
• The Visby Medical Respiratory Health 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 are indicative of the presence of SARS-CoV-2, influenza A, and/or influenza B nucleic acid, but do not rule out bacterial infection or co-infection with other pathogens not detected by the test
• Negative results for influenza B are presumptive and should be confirmed with an alternative molecular FDA-cleared or authorized assay, if necessary for patient management
• Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for patient management decisions
• True PCR results that detect and differentiate RNA from the viruses that cause flu and COVID-19, in under 30 minutes with lab accuracy in the palm of your hands

More Information

• Visby Medical Respiratory Health Test FDA EUA
• Visby Medical Respiratory Health Test IFU
• Visby Medical Respiratory Health Test Healthcare Providers Fact Sheet
• Visby Medical Respiratory Health Test Patient Fact Sheet