-
,for, Item ID-
- #1249665
- Cue Health Inc #C5203-20
Respiratory Test Kit Cue® COVID-19 Pro Bundle 20 Tests
MONITORING SYS, COVID-19 CUE HLTH CLIA CERTIFIED BUNDLE D/S
Features
- Cue COVID-19 Pro Bundle includes (2) Cue Health Monitoring Systems (C0201) and (2) 10-packs of Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories (C1020)
- 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
- More …
Product Details Email
Product Specifications
McKesson # | 1249665 |
---|---|
Manufacturer # | C5203-20 |
Brand | Cue® |
Manufacturer | Cue Health Inc |
Country of Origin | Unknown |
Application | Respiratory Test Kit |
For Use With | For Cue Health Monitoring System / Cue Health App |
Number of Tests | 20 Tests |
Purchase Program Type | Promotion |
Reading Type | Machine Read |
Sample Type | Anterior Nasal Swab Sample |
Specialty | Molecular |
Test Format | Test Card Format |
Test Kit Type | Rapid |
Test Method | Isothermal Amplication |
Test Name | COVID-19 Pro Bundle |
Test Type | Molecular Diagnostic |
Time to Results | 20 Minute Results |
UNSPSC Code | 41116144 |
Features
- Cue COVID-19 Pro Bundle includes (2) Cue Health Monitoring Systems (C0201) and (2) 10-packs of Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories (C1020)
- 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
- Cue Reader is a durable, intuitive automated processor of test results and is used with Cue tests and the Cue Health App - designed to work with Cue's COVID-19 tests as well as future tests
- The Cue Cartridge Reader features 5 LED indicator lights located on the top of the Cue Cartridge Reader
- The Cue Reader runs single-use cartridges and communicates the result of the test digitally via Bluetooth® to the Cue Health App
- Once the Cue Wand with the nasal sample is inserted into the pre-heated Cue Test Cartridge, the Cue Reader will process the test and communicate the result directly to the Cue Health App on your mobile device via Bluetooth®
More Information
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