bd max system covid

© 2020 BD. The solution also offers configured reporting capabilities, which allow customers in the U.S. to generate reports in accordance with the U.S. Coronavirus Aid, Relief, and Economic Security (CARES) Act. BD Synapsys™ Informatics is an optional integrated informatics solution available to customers using the BD Veritor™ Plus System, a portable instrument delivering SARS-CoV-2 antigen test results in approximately 15 minutes, and the BD MAX™ System, a molecular diagnostic platform returning results in two to three hours. "BD Synapsys™ Informatics unifies instrument-read COVID-19 test results from the BD Veritor™ and BD MAX™ systems," said Rajeev Sehgal, director of Informatics for BD Integrated Diagnostics Solutions. Learn more about BD Synapsys. For more information on BD, please visit bd.com. This empowers customers to focus on what matters most: Caring for their patients.". The BD SARS-CoV-2 Reagent Kit for BD MAX™ System has been CE marked to the IVD Directive (98/79/EC), but it has not been cleared or approved by FDA. For more information on BioGX, please visit BioGX.com. Browse the expanding catalog of BD products across a wide range of care areas, specialties and brands. The companies submitted the Emergency Use Authorization requests to FDA today. It is a versatile, digitally analyzed system that removes result ambiguity and provides lab level performance with assays for SARS-CoV-2, Flu A+B, Group A Strep and RSV. 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. The test will be run on the BD MAX System, a molecular diagnostic platform already in use at hundreds of laboratories in nearly every state across the country. BioGX launches CE-IVD Marked COVID-19, Influenza A/B, RSV Combo RT-PCR Test for the BD MAX™ System USA - English USA - English News provided by . Contacts: Mela Sera, APR                                                      BD Public Relations                                                443-824-8012                                                      Mela.Sera@bd.com, Kristen M. Stewart, CFABD Strategy & Investor Relations201-847-5378Kristen.Stewart@bd.com, View original content to download multimedia:http://www.prnewswire.com/news-releases/bd-announces-streamlined-reporting-capabilities-for-covid-19-data-301178592.html, SOURCE BD (Becton, Dickinson and Company), Improving medication availability through Pyxis Pharmogistics™ and the Pyxis™ ES Platform. https://www.bd.com/fr-fr/offerings/molecular-diagnostics/hais/bd-max Testing is limited to U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 … Rapid point-of-care solution for patients that are showing COVID-19 symptoms . 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. SOURCE BD (Becton, Dickinson and Company). About BD Synapsys™ Informatics BD Synapsys™ Informatics is the informatics platform for BD diagnostics systems, including the BD Veritor™ Plus System and the BD MAX™ System, which have been granted Emergency Use Authorization by the U.S. Food and Drug Administration to perform SARS-CoV-2 diagnostic testing. The BD MAX™ System, a molecular diagnostic platform, is widely used in hundreds of laboratories across Europe. Browse the expanding catalog of BD products across a wide range of care areas, specialties and brands. All rights reserved. Authorization to use our test would increase access across the U.S. to an automated, highly reliable SARS-CoV-2 test.". BioGX developed the assay for the BD MAX™ System in their Sample-Ready™ ready-to-use format to detect the presence of the SARS-CoV-2 virus, the cause of COVID-19. It has not been authorized for use to detect any other viruses or pathogens. Patient: Vincent Age: 41 years old After coughing for several days, Vincent was having trouble breathing and had a high fever. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. A nasopharyngeal specimen was collected and analysed for flu, RSV and SARS-CoV-2 on the BD MAX™ System. The BD Veritor™ Plus System is the portable, easy-to-use testing system that delivers reliable results in just minutes. The tests will be run on the BD MAX™ Molecular Diagnostic Platform, which is already in use in nearly every state across the U.S. at hundreds of laboratories, with each unit capable of analyzing hundreds of samples per day. BD is closely monitoring the COVID-19 (coronavirus) situation across the world and guidance from the U.S. Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO) and health officials in a variety of affected countries to protect the health and safety of BD employees while ensuring continued availability of our … Preparing your laboratory for tomorrow ’ s 50+ molecular diagnostic platform, is used. Reports can be developed, as needed just minutes from the virus that causes COVID-19 in respiratory. Up and address such unmet needs with speed on COVID-19 ( Coronavirus ) Updated November 2020 samples per.! Results found for `` [ term ] '' unless the authorization is terminated or revoked.! Test is designed to detect any other viruses or pathogens several days, Vincent having! Empowers customers to focus on what matters most: Caring for their patients. `` the burden with... 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