bd max system covid

BioGX SARS-CoV-2 Reagents for BD MAX System: Results in Table 2A: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Wantai SARS-CoV-2 RT-PCR Kit : … 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. This kit enables BD MAX System users to run a single module that tests for COVID-19 and Influenza (Flu), along with Respiratory Syncytial Virus (“RSV”) at once. Each unit is capable of analyzing hundreds of samples per day. "The new CerTest kit will provide rapid COVID-19 diagnostic capabilities that can be run individually or combined with detection of Flu A, Flu B and RSV A and B," said Nelson Fernandes , managing director of CerTest Biotec. The test is authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. COVID result: Positive. 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. For more information on BD, please visit bd.com. About the BD MAX™ System for Detection of SARS-CoV-2 Assay 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. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Authorization to use our test would increase access across the U.S. to an automated, highly reliable SARS-CoV-2 test.". It has not been authorized for use to detect any other viruses or pathogens. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 … "For COVID-19 testing facilities – including labs, hospitals and nursing homes – the BD Synapsys™ Informatics solution's new reporting capabilities, supported by secure connectivity, simplifies the process of reporting test results to public health authorities.". The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay is not authorized for use by consumers or for at-home use. The BD Synapsys solution's new capabilities allow global customers to create general-purpose reports with COVID-19 data from their BD Veritor and/or BD MAX systems. The BD MAX System is designed to help address today’s challenges, while preparing your laboratory for tomorrow’s possibilities. BD Announces Streamlined Reporting Capabilities for COVID-19 Data, Medication and supply management software, Medication and supply management technologies, Browse all medication and supply management products, Identification and susceptibility testing, Browse all microbiology solutions products, Patient monitoring and temperature management, Critical and emergency care patient monitoring, Browse patient monitoring and temperature management, V Mueller and Snowden-Pencer open instrumentation, Healthcare-associated infection prevention, http://www.prnewswire.com/news-releases/bd-announces-streamlined-reporting-capabilities-for-covid-19-data-301178592.html. … The test is designed to detect viral nucleic acid from the virus that causes COVID-19 in upper respiratory specimens, such as nasal swabs. "These are challenging times for all of us, more so for our laboratory partners who have an urgent need for an easy to use, reliable test to detect the SARS-CoV-2 to determine if patients have contracted COVID-19," said Shazi Iqbal, Ph.D., chief executive officer of BioGX. 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. BioGX operates in a cGMP compliant environment certified to International Standard ISO 13485. "The foundation of BioGX firmly stands on its team's ability to step up and address such unmet needs with speed. BD Statement on COVID-19 (Coronavirus) Updated November 2020. BD, BioGX Announce FDA Emergency Use Authorization Submissions for New COVID-19 Diagnostics for Use in U.S. New Diagnostics Have Potential to Increase Capacity of COVID-19 Testing in U.S. by Thousands of Tests Per Day, Medication and supply management software, Medication and supply management technologies, Browse all medication and supply management products, Identification and susceptibility testing, Browse all microbiology solutions products, Patient monitoring and temperature management, Critical and emergency care patient monitoring, Browse patient monitoring and temperature management, BD Recykleen sharps collectors and accessories, V Mueller and Snowden-Pencer open instrumentation, Healthcare-associated infection prevention. Each BD MAX™ System can process 24 samples simultaneously. The Emergency Use Authorization authority allows FDA to help strengthen the nation's public health protections against chemical, biological, radiological and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. 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. workers for COVID-19. "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. https://www.bd.com/fr-fr/offerings/molecular-diagnostics/hais/bd-max SOURCE BD (Becton, Dickinson and Company). This empowers customers to focus on what matters most: Caring for their … The BD MAX System is a fully-integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in … The BD SARS-CoV-2 Reagents for BD MAX™ System is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. Please try new keyword. The Sample-ReadyTM technology is at the core of all product offerings for Clinical, Food Safety, Pharma and Water Quality molecular testing. All rights reserved. This empowers customers to focus on what matters most: Caring for their patients.". Browse the expanding catalog of BD products across a wide range of care areas, specialties and brands. "Our BD MAX System is a versatile molecular platform that enables us to rapidly deliver molecular solutions across our laboratory customers and help communities in need during times of high anxiety.". 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 BD MAX™ System is a fully-integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in less than three hours*. "The solution's new encrypted reporting capabilities reduce the burden associated with manual reporting. FRANKLIN LAKES, N.J. and BIRMINGHAM, Ala., March 16, 2020 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and BioGX Inc, a molecular diagnostics company, today announced that the companies have submitted Emergency Use Authorization requests to the U.S. Food and Drug Administration (FDA) for new diagnostic tests that, if authorized, would increase the potential capacity to screen for COVID-19 (coronavirus) by thousands of tests per day. "The collaboration with BioGX to deliver a COVID-19 diagnostic in the U.S. is another example of BD's commitment to help with the global COVID-19 pandemic and combat the spread of infectious diseases," said Nikos Pavlidis, vice president and general manager, molecular diagnostics and women's health for BD. PerkinElmer's New Coronavirus Nucleic Acid Detection Kit was found to be the most sensitive test, with the ... Dickinson's BioGX SARS CoV-2 test for the BD MAX system… Unless otherwise noted, BD, the BD Logo and all other trademarks are the property of Becton, Dickinson and Company or its affiliates. © 2020 BD. 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. This kit allows BD MAX™ System users to run a single module that tests concurrently for COVID-19 and Influenza (Flu) and Respiratory Syncytial Virus (RSV). The test has been authorized by FDA under an EUA for use by authorized laboratories. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. The system is fully automated, reducing the opportunity for human error and increasing the speed to result. This kit allows BD MAX™ System users to run a single module that tests concurrently for COVID-19 and Influenza (Flu) and Respiratory Syncytial Virus (RSV). 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 . The assay is based on the same viral RNA targeting sequences and real-time PCR detection method as the test developed by the U.S. Centers for Disease Control and Prevention (CDC). 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. • The BD SARS-CoV-2 Reagents for BD MAX™ System can be used to test nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or … It has not been authorized for use to detect any other viruses or pathogens. BD's (BDX) Real Time PCR Detection Kit enables BD MAX System users to run a single module that tests concurrently for COVID-19, flu and RSV. Rapid point-of-care solution for patients that are showing COVID-19 symptoms . About the BD Veritor™ System for Rapid Detection of SARS-CoV-2 Assay The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay has been CE marked to the IVD Directive (98/79/EC), but has not been cleared or approved by FDA. All rights reserved. Discover Vincent's story. Ferrari Productions (www.ferrariproductions.com) shot and edited this video for BD, as an instructional aid for operating the device. © 2020 BD. Additional configured reports can be developed, as needed. A nasopharyngeal specimen was collected and analysed for flu, RSV and SARS-CoV-2 on the BD MAX™ System. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 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