Molecular Diagnostic Control Swab Kit Cue™ COVID-19 Positive Level / Negative Level 6 Swabs
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
Product Specifications
Description
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
Cue COVID-19 External Control Swabs Pack (REF C2110) contains three Cue COVID-19 Test Positive Control Swabs (REF C2111) and three Cue Test Negative Control Swabs (REF C2112)
