Description
For use with the BD Veritor Plus
Covid Flu A+B Patient Fact Sheet
Covid Flu A+B Provider Fact Sheet
Unit: 1 box- 30 tests/box
Regulatory Status: FDA Emergency Use Authorized- CLIA Waived / Professional Use Only
Test Time: 15 Minutes
Contents: (30) BD Veritor™ System SARS-CoV-2 & Flu A+B combined tests, (30)sample collection swabs, BD Veritor™ System Extraction Reagent, tube trays, Positive control swabs (SARS-CoV-2, Flu A, Flu B)
BD SARS-CoV2 Test & Flu A+B Cassettes Require a BD Veritor-Plus Analyzer with ROM Version 5.4 or Higher. A USB upgrade Key 445006 provided at no charge with order of test cassettes if needed!!!
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. Emergency use of this test is limited to authorized laboratories.
The system has an unique adaptive read technology – helps reduce false-positive results by examining the sample and compensating for many of the effects of non-specific binding to help deliver a more accurate read. Eliminates the need for visual-read and subjective interpretation by providing objective results on an easy-to-read digital display. Delivers results in minutes
- Easy operation and 1-button functionality may potentially reduce manual test processing errors
- Enables intuitive sample processing with prefilled, unitized tubes color-coded by reagent or assay type
- Displays easy-to-read digital results for SARS-CoV-2 and Flu A+B in 15 minutes
- Records results on secured drive
- Advanced particle technology enhances sensitivity by using a proprietary process to produce highly stable, modified colloidal metal particles, helping improve test performance
- Adaptive read technology helps improve specificity to reduce false-positive results by compensating for background and nonspecific binding
- *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; and,
- 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.
