BD Receives FDA 510(k) Clearance for Rapid Point-of-Care COVID-19 Test
BD (NYSE:BDX) has received FDA 510(k) clearance for its BD Veritor鈩� System for SARS-CoV-2, a rapid COVID-19 antigen test. The digital test delivers results in approximately 15 minutes at various point-of-care locations including doctors' offices, urgent care centers, and retail clinics.
The test, previously available under Emergency Use Authorization since September 2020, will transition to the new FDA-cleared version in early fall 2025. The BD Veritor鈩� System uses chromatographic digital lateral flow immunoassay technology to provide objective results from nasal swab specimens taken within six days of symptom onset, and is designed for use in CLIA-waived environments.
BD (NYSE:BDX) ha ottenuto la approvazione FDA 510(k) per il suo sistema BD Veritor鈩� per SARS-CoV-2, un test antigenico rapido per il COVID-19. Il test digitale fornisce risultati in circa 15 minuti in diversi punti di assistenza, tra cui studi medici, centri di pronto soccorso e cliniche al dettaglio.
Il test, precedentemente disponibile con l'Autorizzazione all'Uso d'Emergenza dal settembre 2020, passer脿 alla nuova versione approvata dalla FDA all'inizio dell'autunno 2025. Il sistema BD Veritor鈩� utilizza la tecnologia immunoenzimatica digitale a flusso laterale cromatografico per fornire risultati oggettivi da campioni prelevati con tampone nasale entro sei giorni dall'insorgenza dei sintomi, ed 猫 progettato per l'uso in ambienti CLIA-waived.
BD (NYSE:BDX) ha recibido la autorizaci贸n FDA 510(k) para su sistema BD Veritor鈩� para SARS-CoV-2, una prueba r谩pida de ant铆geno para COVID-19. La prueba digital ofrece resultados en aproximadamente 15 minutos en diversos puntos de atenci贸n, incluyendo consultorios m茅dicos, centros de atenci贸n urgente y cl铆nicas minoristas.
La prueba, que estuvo disponible bajo Autorizaci贸n de Uso de Emergencia desde septiembre de 2020, pasar谩 a la nueva versi贸n aprobada por la FDA a principios del oto帽o de 2025. El sistema BD Veritor鈩� utiliza tecnolog铆a de inmunoensayo digital de flujo lateral cromatogr谩fico para proporcionar resultados objetivos a partir de muestras tomadas con hisopo nasal dentro de los seis d铆as posteriores al inicio de los s铆ntomas, y est谩 dise帽ado para su uso en entornos CLIA-waived.
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BD (NYSE:BDX) a obtenu l'autorisation FDA 510(k) pour son syst猫me BD Veritor鈩� pour le SARS-CoV-2, un test antig茅nique rapide pour la COVID-19. Ce test num茅rique fournit des r茅sultats en environ 15 minutes dans divers lieux de soins, notamment les cabinets m茅dicaux, les centres de soins d'urgence et les cliniques de d茅tail.
Le test, disponible auparavant sous Autorisation d'Utilisation d'Urgence depuis septembre 2020, passera 脿 la nouvelle version approuv茅e par la FDA au d茅but de l'automne 2025. Le syst猫me BD Veritor鈩� utilise une technologie d'immunodosage num茅rique 脿 flux lat茅ral chromatographique pour fournir des r茅sultats objectifs 脿 partir d'茅chantillons pr茅lev茅s par 茅couvillon nasal dans les six jours suivant l'apparition des sympt么mes, et est con莽u pour 锚tre utilis茅 dans des environnements exempt茅s CLIA.
BD (NYSE:BDX) hat die FDA 510(k)-Zulassung f眉r sein BD Veritor鈩� System f眉r SARS-CoV-2 erhalten, einen schnellen COVID-19-Antigentest. Der digitale Test liefert Ergebnisse in etwa 15 Minuten an verschiedenen Point-of-Care-Standorten, darunter Arztpraxen, Notfallzentren und Einzelhandelskliniken.
Der Test, der seit September 2020 unter einer Notfallzulassung verf眉gbar war, wird im fr眉hen Herbst 2025 auf die neue FDA-zugelassene Version umgestellt. Das BD Veritor鈩� System verwendet eine chromatographische digitale Lateral-Flow-Immunoassay-Technologie, um objektive Ergebnisse aus Nasenabstrichproben zu liefern, die innerhalb von sechs Tagen nach Symptombeginn entnommen wurden, und ist f眉r die Verwendung in CLIA-befreiten Umgebungen konzipiert.
- FDA 510(k) clearance represents a higher regulatory standard than the previous Emergency Use Authorization
- Rapid 15-minute result time enables quick clinical decision-making
- Wide accessibility through various point-of-care locations
- Digital results system reduces human interpretation errors
- Limited to testing symptomatic patients within 6 days of symptom onset
- Requires specific analyzer hardware (BD Veritor鈩� Plus Analyzer) to process results
New听CLIA-Waived Test Delivers Digital Results to Support Timely Clinical Decision-Making
The BD Veritor鈩� System for SARS-CoV-2听has been available under Emergency Use Authorization (EUA) from the FDA since September 2020. The new 510(k) clearance will eventually replace the current EUA version of the test, starting in early fall 2025.
"This FDA clearance is part of our ongoing commitment to support health care providers with reliable, rapid diagnostic tools," said Nikos Pavlidis, worldwide president of BD Diagnostic Solutions. "The BD Veritor鈩� System for SARS-CoV-2听has proven to be a reliable COVID-19 test with a streamlined workflow and clear digital results, helping clinicians make confident and timely decisions that can help improve patient outcomes."
The BD Veritor鈩� System for SARS-CoV-2 is a chromatographic, digital lateral flow immunoassay that delivers objective, easy-to-read results using the BD Veritor鈩� Plus Analyzer. The test is intended for use in CLIA-waived environments and provides results from nasal swab specimens from patients within six days of symptom onset.
For more information or support, customers can contact BD Customer Service at 800-638-8663.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit or connect with us on LinkedIn at , X (formerly Twitter) or Instagram
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FAQ
What type of FDA approval did BD (BDX) receive for its COVID-19 test in July 2025?
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