BD Receives FDA 510(k) Clearance for Rapid Point-of-Care COVID-19 Test

Core Points - BD has received FDA 510(k) clearance for the BD Veritor™ System for SARS-CoV-2, a digital test for detecting COVID-19 antigens in symptomatic individuals within approximately 15 minutes [1][2] - The BD Veritor™ System has been available under Emergency Use Authorization since September 2020, and the new clearance will replace the EUA version starting in early fall 2025 [3] - The system is designed for use in CLIA-waived environments and provides results from nasal swab specimens within six days of symptom onset, enhancing timely clinical decision-making [4] Company Overview - BD is one of the largest global medical technology companies, focusing on improving medical discovery, diagnostics, and care delivery [6] - The company employs over 70,000 individuals and is committed to enhancing the safety and efficiency of healthcare delivery processes [6] - BD collaborates with organizations worldwide to address significant global health challenges, aiming to improve outcomes, lower costs, and expand healthcare access [6]