Respiratory Test Kit Visby Medical
COVID-19 / Influenza A + B 20 Tests CLIA Waived
Visby Medical PS-400380

Respiratory Test Kit Visby Medical
COVID-19 / Influenza A + B 20 Tests CLIA Waived
Visby Medical PS-400380

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

Manufacturer # PS-400380 Brand Visby Medical™ Manufacturer Visby Medical Country of Origin United States Application Respiratory Test Kit CLIA Classification CLIA Waived CLIA Classified CLIA Waived Contents 1 (20) Visby Medical Respiratory Health Test Devices, (24) 650 µL Pipettes, (24) Buffer Tubes, (24) Disposable Bags Number of Tests 20 Tests Purchase Program Type Standard Purchase Reading Type Visual Read Sample Type Anterior Nasal / Nasopharyngeal Swab Sample Specialty Molecular Technology Colorimetric Test Format Test Device Format Test Kit Type Rapid Test Name COVID-19 / Influenza A + B Test Type RT-PCR Time to Results 30 Minute Results UNSPSC Code 41116205 Volume 5.9 mL