Respiratory Test Kit Revogene® SARS-CoV-2 24 Test CLIA Non-Waived

Features

• The Revogene® SARS-CoV-2 assay is for Emergency Use Authorization (EUA) Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
• Automated, streamlined workflow, sample to result in three easy steps with less than two minutes of hands on time
• 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 or moderate complexity tests
• Positive results are indicative of the presence of SARS CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
• Revogene® is a flexible molecular platform that can help standardize testing throughout your health system
• Turnaround time: 85 minutes, with as early as 47 minutes for positive specimens with EPro - early call feature

More Information

• Revogene SARS-CoV-2 Test FDA EUA Letter
• Revogene SARS-CoV-2 Test IFU
• Revogene SARS-CoV-2 Test Brochure
• Revogene SARS-CoV-2 Test Healthcare Provders Fact Sheet
• Revogene SARS-CoV-2 Test Patients Fact Sheet