Features

• Visby Respiratory Promo Pack - (1) case of Respiratory Health Tests (20 devices), (2) Visby Power Adaptors, (1) Pack of Respiratory Health Control Swabs (2 pos/2 neg)
• Visby Medical Respiratory Health Test has received 510(k) clearance and a CLIA waiver from the FDA for use in CLIA-waived settings: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Detail.cfm?ID=39778
• 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 the indentified virus, but do not rule out bacterial infection or co-infection with other organisms not detected by the test
• The agent(s) detected by the Visby Medical Respiratory health test may not be the definitive cause of disease
• 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

Product Specifications