Cue Health Inc C1020 - Respiratory Test… | USA MedPremium
Respiratory Test Kit Cue™ COVID-19 10 Tests
USAMP#27596020SKU: C1020Cue™
Product Spotlight
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 (Ref C2110)
