{"id":903976,"date":"2025-11-03T07:56:15","date_gmt":"2025-11-03T12:56:15","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system\/"},"modified":"2025-11-03T07:56:15","modified_gmt":"2025-11-03T12:56:15","slug":"bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system\/","title":{"rendered":"BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR\u2122 System"},"content":{"rendered":"
\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n
\n FRANKLIN LAKES, N.J.<\/span>
\n <\/span>, Nov. 3, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0BD (Becton, Dickinson and Company) (NYSE: BDX)\u00a0a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformit\u00e9 Europ\u00e9enne (CE) marking in the European Union for its Enteric Bacterial Panel* (EBP) and Enteric Bacterial Panel plus<\/i>* (EBP plus<\/i>) for the BD COR\u2122 System.<\/p>\n

\n

\n
\n \"BD
\n <\/a>\n <\/p>\n<\/p><\/div>\n

By leveraging advanced Polymerase Chain Reaction (PCR) technology with streamlined testing for a broad range of gastrointestinal (GI) bacterial pathogens from a single stool swab sample, the panels simplify workflows helping clinicians deliver timely, targeted care.\u00a0<\/p>\n

GI infections cause billions of illnesses and more than 1.7 million deaths globally each year, disproportionately affecting young children, older adults, and immunocompromised peoplei<\/sup>. In the United States<\/span>, diarrhea accounts for an estimated 179 million outpatient visits, 500,000 hospitalizations, and more than 5,000 deaths annually, resulting in approximately one episode of acute diarrheal illness per person per yearii<\/sup>. These figures highlight the urgent need for rapid, accurate diagnostics to improve outcomes and support antimicrobial stewardship.<\/p>\n

“Traditional GI tests can take days, and when patients are experiencing symptoms such as diarrhea or vomiting, delays can be potentially life-threatening,” said Nikos Pavlidis<\/span>, worldwide president of BD Diagnostic Solutions. “With EBP and EBP plus<\/i>, clinicians choose the panel that best fits their clinical needs to quickly identify specific pathogens from a single swab, streamlining lab workflows and enabling targeted treatment to help protect vulnerable patients.”<\/p>\n

BD EBP for BD COR\u2122 System offers a wide range of targets for enteric bacterial pathogens, including Salmonella<\/i> spp., Campylobacter<\/i> spp. (jejuni<\/i> and coli<\/i>), Shigella<\/i> spp.\/Enteroinvasive Escherichia coli<\/i> (EIEC), and Shiga toxin-producing Escherichia coli<\/i> (STEC).<\/p>\n

BD EBP plus<\/i> for BD COR\u2122 System is the only high-throughput, bacterial-only molecular panel that detects Enterotoxigenic Escherichia coli (ETEC), heat-labile enterotoxin (LT) and heat-stable enterotoxin (ST) genes, enabling improved patient management through rapid identification for targeted treatment of this major cause of diarrheal illness and helping reduce unnecessary antibiotic useiii<\/sup>. The panel also identifies\u00a0Plesiomonas shigelloides, Vibrio spp. (V. vulnificus, V. parahaemolyticus, V. cholerae)<\/i>, and Yersinia enterocolitica<\/i>.<\/p>\n

The panels are run on the BD COR\u2122 System, which automates molecular lab workflows with capacity for nearly 1,650 tests while delivering up to 1,000 sample results in 24 hours with barcode-driven traceability and remote system management. It offers up to seven hours of walk-away time, requires under 15 minutes to load, and uses room-temperature reagents that require no reconstitution, maximizing efficiency and minimizing manual interaction.<\/p>\n

BD also offers the BD MAX\u2122 Enteric Bacterial, Extended Enteric Bacterial, Enteric Viral and Enteric Parasite\u00a0targeted syndromic panels for timely, accurate detection of the most common bacterial, viral and parasitic pathogens responsible for infectious diarrhea.<\/p>\n

“With the BD MAX\u2122 System, BD has long supported flexible, efficient, reliable enteric pathogen testing with more than 10 assays across respiratory, hospital acquired infection, sexually transmitted infection, and women’s health testing for hospitals, clinics, and reference labs,” said Pavlidis. “The addition of these two enteric panels to the BD COR\u2122 system enables high-volume laboratories to advance their standard of care and optimize operational workflows.”<\/p>\n

\n About\u00a0BD<\/b>\n <\/p>\n

BD is\u00a0one of the\u00a0largest global medical\u00a0technology\u00a0companies\u00a0in the\u00a0world\u00a0and is\u00a0advancing\u00a0the 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\u00a0virtually\u00a0every\u00a0country\u00a0and\u00a0partners\u00a0with\u00a0organizations\u00a0around\u00a0the\u00a0world to\u00a0address\u00a0some\u00a0of the\u00a0most\u00a0challenging\u00a0global\u00a0health issues.\u00a0By\u00a0working in\u00a0close\u00a0collaboration\u00a0with\u00a0customers,\u00a0BD 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<\/a><\/u>\u00a0or connect with us on LinkedIn at www.linkedin.com\/company\/bd1\/<\/a><\/u>, X (formerly Twitter) @BDandCo<\/a><\/u>\u00a0or Instagram @becton_dickinson<\/a><\/u><\/p>\n

\n\n\n\n\n
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\n
\n Contacts:<\/b>
\n <\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n<\/tr>\n
\n

\n
\n Media<\/u>
\n <\/span>\n <\/p>\n<\/td>\n

\n

\n
\n Investors<\/u>
\n <\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n Fallon McLoughlin
Director, Public Relations
201.258.0361\u00a0
Fallon.Mcloughlin@bd.com<\/a> \u00a0<\/span>\n <\/p>\n<\/td>\n

\n

\n Adam Reiffe\u00a0<\/span>\n <\/p>\n

\n Vice President, Investor Relations<\/span>\n <\/p>\n

\n 201.847.6927\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/span>\n <\/p>\n

\n
\n Adam.Reiffe@bd.com<\/a>\u00a0<\/span>\n <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n

\n i <\/sup>
\n https:\/\/bmcpublichealth.biomedcentral.com\/articles\/10.1186\/s12889-024-21270-6<\/a>
\n
\n
ii<\/sup>
\n https:\/\/www.aafp.org\/pubs\/afp\/issues\/2022\/0700\/acute-diarrhea.pdf<\/a>
\n
\n
iii<\/sup>
\n https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC5925700\/pdf\/e00148-18.pdf<\/a>\n <\/p>\n

\u00a0<\/p>\n

\n

\n
\n \"BD
\n <\/a>\n <\/p>\n<\/p><\/div>\n

\n \"Cision\" View original content to download multimedia:https:\/\/www.prnewswire.com\/news-releases\/bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system-302601892.html<\/a><\/p>\n

SOURCE BD (Becton, Dickinson and Company)<\/p>\n<\/p><\/div>\n

\"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

PR Newswire FRANKLIN LAKES, N.J. , Nov. 3, 2025 \/PRNewswire\/ —\u00a0BD (Becton, Dickinson and Company) (NYSE: BDX)\u00a0a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformit\u00e9 Europ\u00e9enne (CE) marking in the European Union for its Enteric Bacterial Panel* (EBP) and Enteric Bacterial Panel plus* (EBP plus) for the BD COR\u2122 System. By leveraging advanced Polymerase Chain Reaction (PCR) technology with streamlined testing for a broad range of gastrointestinal (GI) bacterial pathogens from a single stool swab sample, the panels simplify workflows helping clinicians deliver timely, targeted care.\u00a0 GI infections cause billions of illnesses and more than 1.7 million deaths globally each year, disproportionately affecting young children, older adults, and … <\/p>\n

Continue reading “BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR\u2122 System”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-903976","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nBD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR\u2122 System - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR\u2122 System - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire FRANKLIN LAKES, N.J. , Nov. 3, 2025 \/PRNewswire\/ —\u00a0BD (Becton, Dickinson and Company) (NYSE: BDX)\u00a0a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformit\u00e9 Europ\u00e9enne (CE) marking in the European Union for its Enteric Bacterial Panel* (EBP) and Enteric Bacterial Panel plus* (EBP plus) for the BD COR\u2122 System. 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system\/","og_locale":"en_US","og_type":"article","og_title":"BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR\u2122 System - Market Newsdesk","og_description":"PR Newswire FRANKLIN LAKES, N.J. , Nov. 3, 2025 \/PRNewswire\/ —\u00a0BD (Becton, Dickinson and Company) (NYSE: BDX)\u00a0a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformit\u00e9 Europ\u00e9enne (CE) marking in the European Union for its Enteric Bacterial Panel* (EBP) and Enteric Bacterial Panel plus* (EBP plus) for the BD COR\u2122 System. By leveraging advanced Polymerase Chain Reaction (PCR) technology with streamlined testing for a broad range of gastrointestinal (GI) bacterial pathogens from a single stool swab sample, the panels simplify workflows helping clinicians deliver timely, targeted care.\u00a0 GI infections cause billions of illnesses and more than 1.7 million deaths globally each year, disproportionately affecting young children, older adults, and … Continue reading \"BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR\u2122 System\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system\/","og_site_name":"Market Newsdesk","article_published_time":"2025-11-03T12:56:15+00:00","og_image":[{"url":"https:\/\/mma.prnewswire.com\/media\/2810821\/LAB_Tech_Screen.jpg","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR\u2122 System","datePublished":"2025-11-03T12:56:15+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system\/"},"wordCount":781,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system\/#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnewswire.com\/media\/2810821\/LAB_Tech_Screen.jpg","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/bd-receives-fda-510k-clearance-and-ce-ivdr-certification-for-high-throughput-enteric-bacterial-panels-on-bd-cor-system\/","name":"BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR\u2122 System - 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