BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B

Description

Rapidly detect and differentiation between SARS-CoV-2, Flu A, and Flu B from one sample on one assay in 15 minutes with the newest BD Veritor assay.

• Detect and differentiate between SARS-CoV-2, Flu A, and Flu B from one sample on one assay in just 15 minutes
• Identical workflow to the SARS-CoV-2 assay Dual anterior nares sample collection. Clear, digitally displayed results that detect positives not recognized by the unaided eye
• Requires BD Veritor Plus Analyzers running firmware v5.50 or higher
• Check out seasonal promotions for offers that include free analyzers with the purchase of kits.

Specifications

• Certifications/Compliance: Certificate of Conformance
• Content And Storage: 2°C to 30°C
• Control Sets: SARS+, Flu A+, Flu B+ included
• CPT Code: 87428
• CE Marker: No
• Clia Complexity: Waived
• Detectable Analytes: SARS-CoV-2, Influenza A/B
• DoA Calibrators: No
• Sample Type: Dual Anterior Nares
• Sensitivity: 86.7% (SARS-CoV-2)
• Type: Rapid Antigen
• For Use With (Application): Lateral Flow Immunoassay
• For Use With (Equipment): BD Veritor Plus Analyzer (256066)
• Quantity: 30 Tests
• Specificity: 0.995
• Test Time: 15 min.
• Form: Liquid

*The BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B is intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and/or influenza A and B nucleoprotein antigens directly from anterior nasal swab samples taken from individuals who are suspected of a viral respiratory infection consistent with COVID-19 by a healthcare provider, within the first six days of symptom onset.

• This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories.
• This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens.
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.