BD Veritor System Infectious Disease Immunoassay SARS-CoV-2 Nasal

The BD Veritor System for Rapid Detection of SARS-CoV-2 is a chromatographic immunoassay for the direct and qualitative detection of SARS-CoV-2 antigens in nasal swabs from patients with signs and symptoms who are suspected of COVID-19.

Features/Benefits:

Simplify the testing process

• Easy operation and 1-button functionality may help reduce manual test processing errors
• Simple sample processing with color-coded tubes

Achieve fast, reliable results

• Displays easy-to-read digital results for COVID-19 in 15 minutes: “CoV2: +” for positive, “CoV2: -” for negative
• Records results on secured internal drive
• Advanced particle technology helps improve test performance*

Provide workflow efficiency

• Adapts easily to your workflow by offering 2 operational modes
  - Walk away: Test device is inserted immediately into Analyzer, so staff can multi-task while sample incubates (15 minutes)
  - Analyze now: Test device is inserted after incubation time is complete, allowing batches of samples to be tested (results in seconds)

Provide result traceability

• Download and display Lot number, patient/specimen ID, Operator ID and test records with BD Veritor^™ InfoScan module
• Offers result-printing capabilities via USB port

 *in comparison to visually read tests

FDA Disclaimers:

• 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, not for any other viruses or pathogens; and
• 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.