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™ 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™ 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™ 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, passerà alla nuova versione approvata dalla FDA all'inizio dell'autunno 2025. Il sistema BD Veritor™ 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 è progettato per l'uso in ambienti CLIA-waived.
BD (NYSE:BDX) ha recibido la autorización FDA 510(k) para su sistema BD Veritor™ para SARS-CoV-2, una prueba rápida de antígeno para COVID-19. La prueba digital ofrece resultados en aproximadamente 15 minutos en diversos puntos de atención, incluyendo consultorios médicos, centros de atención urgente y clínicas minoristas.
La prueba, que estuvo disponible bajo Autorización de Uso de Emergencia desde septiembre de 2020, pasará a la nueva versión aprobada por la FDA a principios del otoño de 2025. El sistema BD Veritor™ utiliza tecnología de inmunoensayo digital de flujo lateral cromatográfico para proporcionar resultados objetivos a partir de muestras tomadas con hisopo nasal dentro de los seis días posteriores al inicio de los síntomas, y está diseñado para su uso en entornos CLIA-waived.
BD (NYSE:BDX)는 FDA 510(k) 승인을 BD Veritor™ SARS-CoV-2 시스템에 대해 받았습니다. 이 빠른 COVID-19 항원 검사는 의사 진료소, 응급 치료 센터, 소매 클리닉 등 다양한 현장 진료 장소에서 약 15분 내에 결과를 제공합니다.
이 검사는 2020년 9월부터 긴급 사용 승인 하에 제공되었으며, 2025년 초가을에 새 FDA 승인 버전으로 전환될 예정입니다. BD Veritor™ 시스템은 디지털 측면 유동 크로마토그래피 면역측정 기술을 사용하여 증상 발현 후 6일 이내에 채취한 비강 면봉 샘플에서 객관적인 결과를 제공하며, CLIA 면제 환경에서 사용하도록 설계되었습니다.
BD (NYSE:BDX) a obtenu l'autorisation FDA 510(k) pour son système BD Veritor™ pour le SARS-CoV-2, un test antigénique rapide pour la COVID-19. Ce test numérique fournit des résultats en environ 15 minutes dans divers lieux de soins, notamment les cabinets médicaux, les centres de soins d'urgence et les cliniques de détail.
Le test, disponible auparavant sous Autorisation d'Utilisation d'Urgence depuis septembre 2020, passera à la nouvelle version approuvée par la FDA au début de l'automne 2025. Le système BD Veritor™ utilise une technologie d'immunodosage numérique à flux latéral chromatographique pour fournir des résultats objectifs à partir d'échantillons prélevés par écouvillon nasal dans les six jours suivant l'apparition des symptômes, et est conçu pour être utilisé dans des environnements exemptés CLIA.
BD (NYSE:BDX) hat die FDA 510(k)-Zulassung für sein BD Veritor™ System für 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 verfügbar war, wird im frühen Herbst 2025 auf die neue FDA-zugelassene Version umgestellt. Das BD Veritor™ 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 für 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™ Plus Analyzer) to process results
New CLIA-Waived Test Delivers Digital Results to Support Timely Clinical Decision-Making
The BD Veritor™ System for SARS-CoV-2 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™ System for SARS-CoV-2 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™ System for SARS-CoV-2 is a chromatographic, digital lateral flow immunoassay that delivers objective, easy-to-read results using the BD Veritor™ 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 bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson
Contacts:
Media: Troy Kirkpatrick VP, Public Relations 858.617.2361 | Investors: Adam Reiffe Sr. Director, Investor Relations 201.847.6927 |
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SOURCE BD (Becton, Dickinson and Company)
FAQ
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