Hospitals and laboratories that use a BD MAX™ System can order tests through their BD sales representative. Capability Hazardous drug safety Hernia repair and fixation Two studies were completed to determine clinical performance. BD BioGX SARS-CoV-2 for BD MAX ™ System Anesthesia delivery Syringes and needles BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in U.S. Level: Laboratory Advisory. All of us are striving to navigate the uncertainty of the COVID-19 pandemic. The New Jersey-based company, also known as BD, said a “small number” of nursing homes are reporting multiple false-positive COVID-19 tests … Each unit is capable of analyzing hundreds of samples per day. Audience: Clinical Laboratory Professionals. Drug delivery systems BD Response Plan on COVID-19 (Coronavirus). Specimen collection Here's What That Means You know what they say! The BD MAX™ System, a molecular diagnostic platform, is widely used in hundreds of laboratories across Europe. Infection prevention For more information on BD, please visit bd.com. All rights reserved. In addition, BD continues to work closely with our key suppliers around the world that provide raw materials and components to BD manufacturing plants. The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. On Monday, BD had announced the launch of a point-of-care COVID-19 antigen test that can detect the coronavirus in 15 minutes, the third of its COVID-19 diagnostic test. Support For more on our response efforts, visit our video library. "The collaboration with BD, combined with the new emergency use authorization process from FDA, enabled our companies to bring a new test to the BD MAX™ System quickly and efficiently," said Shazi Iqbal, Ph.D., chief executive officer of BioGX. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Lab automation 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. Learn More. Testing sites should use the following LOINC codes when reporting SARS-CoV-2 antigen test results. Visiting. For U.S. customers, an up-to-date list of products on manual inventory allocation can be found at bd.com/allocation. 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). 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. 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. Hazardous drug safety Biosciences Infection prevention BD also institutes preventative pandemic precautions at facilities to protect employees, including increasing cleaning protocols, implementing temperature screenings for on-site employees, deploying PPE to on-site employees and field workers, implementing social distancing controls in our facilities, supporting work-from-home for all employees who are able, suspending travel and group meetings, limiting on-site visitors, and regularly educating employees about good hygiene and health practices, including social distancing, self-quarantining and handwashing. We are actively monitoring our global logistics and transportation network, taking necessary actions to work around global capacity and border constraints to minimize the risk of any customer delays. BD… Molecular systems The test is only authorized 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. Software solutions It was previously known as 2019 Novel coronavirus (2019-nCov). document.write(new Date().getFullYear()) Microbiology solutions Diabetes care About BioGXBioGX, Inc., headquartered in Birmingham, Alabama, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively "BioGX"), develop and commercialize molecular diagnostics reagents across diverse applications. Vascular surgery 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. Supply management 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, Browse patient monitoring and temperature management, BD Recykleen sharps collectors and accessories, V Mueller and Snowden-Pencer open instrumentation, Healthcare-associated infection prevention, BD Bioscience Solutions to Enable Your COVID-19 Research, BD COVID-19 response, manual inventory allocation, Infection control training from Society for Healthcare Epidemiology of America (SHEA) and BD, Vascular Access and Medication Delivery COVID-19 clinical support resources and FAQs, Medication Management Solutions COVID-19 customer updates, Rapid COVID-19 testing with our BD Veritor, COVID-19 patient care support across the continuum, infection control training from the society for healthcare epidemiology of america and bd, molecular test for the detection of COVID-19 for clinical laboratories in countries recognizing the CE mark, a portable, rapid point-of-care antigen test, CE mark and Emergency Use Authorization (EUA) from the FDA for an additional molecular diagnostics test for COVID-19, launch a new diagnostic test that will enable hospitals to screen for COVID-19 on site, CE mark for combination SARS-CoV-2, Influenza, RSV test on the BD MAX, the launch of the Prevention Course in HAI Knowledge and Control. 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