Transcription of Veritor™ System - BD
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Veritor™ System - BD
256082. 500048916(02). 2020-08. English Veritor System For Rapid Detection of SARS-CoV-2. Kit configured for testing nasal swab samples freshly collected, processed and dispensed directly onto assay test device. In the USA: For use under an Emergency Use Authorization only. 30. Determinations 1. Veritor System For Rapid Detection of SARS-CoV-2. For In Vitro Diagnostic Use For use with the BD Veritor Plus Analyzer running firmware version or later In the USA: For use under an Emergency Use Authorization only Please read these instructions completely before beginning testing of specimens. INTENDED USE. The BD Veritor System for Rapid Detection of SARS-CoV-2 is a chromatographic digital immunoassay intended for the direct and qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swabs from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. In the USA, testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 263a, that meet the requirements to perform moderate, high, or waived complexity tests .
14. Dispose of used BD Veritor System test devices as biohazardous waste in accordance with federal, state and local requirements. 15. Reagents contain sodium azide, which is harmful if inhaled, swallowed or exposed to skin. Contact with acids produces very toxic gas. If there is contact with skin, wash immediately with plenty of water.
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