Respiratory Test Kit Cue
COVID-19 10 Tests
Cue Health C1020

Respiratory Test Kit Cue
COVID-19 10 Tests
Cue Health C1020

Features The Cue™ COVID-19 Test is for use under an 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 Cue COVID-19 Test is an isothermal nucleic acid amplification assay intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in direct anterior nasal swabs or in previously collected anterior nasal swab specimens in viral transport media from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 The test is run using the Cue Health Monitoring System (Cue Cartridge Reader), the Cue COVID-19 Test Cartridge, the Cue Sample Wand, and the Cue Health App on the compatible mobile smart devices named on the Cue Health website at www.cuehealth.com Cue COVID-19 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 Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high, moderate or waived 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 Positive results do not rule out bacterial infection or co-infection with other viruses Testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions Negative results in an asymptomatic individual are presumptive and confirmation may be performed for patient management, if necessary, with a different molecular test in a laboratory Required materials not provided: Cue Health Monitoring System, Mobile Smart Device, Cue Health Mobile App installed on Mobile Smart Device, and Control Swabs

Manufacturer # C1020 Brand Cue™ Manufacturer Cue Health Inc Country of Origin Unknown Application Respiratory Test Kit Contents 1 (10) Cue COVID-19 Test Cartridge Pack: Foil Pouch with Plastic Tray with (1) Single-Use Test Cartridge and (1) Single-Use Wrapped Sterile Cue Sample Wand For Use With For use with Cue Health Monitoring System and Cue Health Mobile Application HCPCS K1034 Number of Tests 10 Tests

Purchase Program Type Standard Purchase Reading Type Machine Read Sample Type Nasal Swab Sample Specialty Molecular Test Format Cartridge Format Test Kit Type Rapid Test Method Isothermal Amplication Test Name COVID-19 Test Type Molecular Diagnostic Time to Results 20 Minute Results UNSPSC Code 41116205