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(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
Product Dating
SLI Medical Acceptable Dating: we will ship >= 30 days
Purchase Program Type
Machine Read
Reading Type
Nasal Swab Sample
Sample Type
Cartridge Format
Specialty
Isothermal Amplication
Test Format
COVID-19 Test for Home and OTC
Test Kit Type
Molecular Diagnostic
Test Method
20 Minute Results
Test Name
41116205
Test Type
Time to Results
UNSPSC Code
Features
The Cue™ COVID-19 Test for Home and Over The Counter (OTC) Use 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
The Cue COVID-19 Test for Home and Over the Counter (OTC) Use is a molecular diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand
Cue COVID-19 Test for Home and Over the Counter (OTC) Use is intended for use in adults (self-swabbing) or children ≥ 2 years of age (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19
Positive results indicate the presence of viral RNA
but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status
Positive results do not rule out a bacterial infection or co-infection with other viruses
Negative results in an asymptomatic individual are presumptive and confirmation with a molecular assay performed in a laboratory
if necessary
for patient management may be performed
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or management decisions for the individual
including infection control decisions
Test results will be reported to relevant public health authorities in accordance with local
state
and federal requirements
using appropriate LOINC and SNOMED codes
as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by the CDC
The test is used with the Cue Reader (sold separately) and the Cue Health App
