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Meridian Bioscience Revogene™ SARS-CoV-2
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Detectable Analytes:
SARS-CoV-2
Description
- The Revogene™ SARS-CoV-2 assay is a real-time RT-PCR test intended for the qualitative detection of RNA from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens from individuals suspected of COVID-19 by their healthcare provider
- Testing is for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet requirements to perform moderate or high complexity tests
- The Revogene™ platform features a fully automated molecular workflow designed to optimize COVID-19 testing capacity
- With its intuitive, press-and-walk-away design, the system streamlines operations into just two easy steps and requires less than one minute of hands-on time
- The assay can deliver positive results as early as 47 min, with negative results available in 85 min
Specifications
Specifications
CE Marker | No |
Clia Complexity | Moderate Complexity |
Detectable Analytes | SARS-CoV-2 |
Detection Method | RT-PCR |
DoA Calibrators | No |
Sample Type | Nasopharyngeal, Oropharyngeal. Anterior Nasal, Mid-Turbinate Nasal Swab Sample |
Type | COVID Test Kit |
Disposable | Single-use |
For Use With (Application) | Nasopharyngeal, Oropharyngeal, Anterior Nasal, and Mid-Turbinate Nasal Swab Specimens |
For Use With (Equipment) | Revogene Instrument (23-029-051) |
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Safety and Handling
WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov
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