- #1224371
- Cue Health Inc #C2110
Molecular Diagnostic Control Swab Kit Cue™ COVID-19 Positive Level / Negative Level 6 Swabs
SWAB PACK, COVID-19 RAPID EXTERNAL 3NEG/3POS D/S
Features
- 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
- 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
- More …
Product Details Email
Product Specifications
McKesson # | 1224371 |
Manufacturer # | C2110 |
Brand | Cue™ |
Manufacturer | Cue Health Inc |
Country of Origin | Unknown |
Application | Control Swab Kit |
For Use With | For use with Cue COVID-19 Test, Cue Reader, Cue Health App |
Levels | Positive Level / Negative Level |
Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
Test Name | COVID-19 |
Test Type | Molecular Diagnostic |
UNSPSC Code | 42141504 |
Volume | 6 Swabs |
Features
- 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
- 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)
More Information
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