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Respiratory Test Kit Cue
COVID-19 Test for Home and OTC 10 Tests
Cue Health C2020
COVID-19 Test for Home and OTC 10 Tests
Cue Health C2020
Product Description
Respiratory Test Kit Cue
COVID-19 Test for Home and OTC 10 Tests
Cue Health C2020
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
Manufacturer # C2020 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 for Home and OTC Test Type Molecular Diagnostic Time to Results 20 Minute Results UNSPSC Code 41116205
COVID-19 Test for Home and OTC 10 Tests
Cue Health C2020
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
Manufacturer # C2020 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 for Home and OTC Test Type Molecular Diagnostic Time to Results 20 Minute Results UNSPSC Code 41116205