Two COVID-19 Serology Tests Get De Novo Marketing Nod
The U.S. Food and Drug Administration (FDA) granted marketing authorization to two COVID-19 serology tests.
Tag: Ortho Clinical Diagnostics
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Ortho Launches First Quantitative COVID-19 IgG Spike Antibody Test and Nucleocapsid Antibody Test
Ortho Clinical Diagnostics offers US laboratories a quantitative COVID-19 test in combination with a nucleocapsid test. Both tests are processed on Ortho's Vitros systems.
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First EUA for High-Volume Covid-19 Antigen Test
Ortho Clinical Diagnostics’ Vitros SARS-CoV-2 Antigen Test has become the first high-volume covid-19 antigen test to receive FDA emergency use authorization.
Ortho Clinical Diagnostics and Quest Diagnostics Broaden Availability of Covid-19 Antibody Testing
The partnership will extend covid-19 antibody testing to more than 20 Quest laboratories across the United States.
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Ortho Clinical Diagnostics Launches Antibody Test for Covid-19
The Vitros Immunodiagnostic Products Anti-SARS-CoV-2 total reagent pack is expected to be available by the end of April.
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FDA Clears Vitros XT MicroSlides with Multitesting Technology
Vitros XT MicroSlides simultaneously deliver accurate results from two miniaturized tests, simplifying workflow and improving lab turnaround time.
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Ortho Microslide with Optics Technology Receives CE Mark
The microslide performs two tests that are commonly ordered together from a single small blood sample for increased efficiency.
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New Microtip Partnership Assays for Diabetes, Cardiac, and Renal Testing
Glycated serum protein, lipoprotein (a), and cystatin c Microtip Partnership assays are now available for use on the Vitros 4600 clinical chemistry system and the Vitros 5600 integrated chemistry and immunoassay system.
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July 2018 Product News
This month’s issue features a thermocycler from Siemens Healthineers, storage tubes from Micronic, and a c-peptide assay from Ortho Clinical Diagnostics.
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Vitros XT 7600 Integrated System Receives CE Mark
Novel diagnostic technology enables powerful data intelligence, operational improvements, and other enhancements in the lab.
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FDA Clears Ortho Clinical Diagnostics Middleware
The customizable middleware system centralizes laboratory operations and workflow across hospitals and networks, allowing blood banks and their data to be confidently managed through one central terminal.
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Ortho to Present 10 Scientific Posters, Seven Products at AACC
At the 2017 annual meeting of the American Association for Clinical Chemistry, Ortho Clinical Diagnostics will present 10 scientific posters highlighting its focus on immunodiagnostics, with discussions on acute kidney injury (AKI), insulin, and infectious disease.
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Holistic Support Program Offers Guidance for Labs, Blood Banks
The program provides traditional onsite support and consulting, and predictive, connected technologies.
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August 2016 Product Spotlight: Hematology, Blood Banking, and Biorepositories
This month’s Product Spotlight features tools for hematology, blood banking, and biorepositories from such companies as Beckman Coulter, Hemo Bioscience, Ortho Clinical Diagnostics, and Sebia.
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Immunoassay Analyzers Improve Service and Quality
Keeping pace with emerging biomarkers, and consolidating a broad test menu, are both important for developing and updating immunoassay instruments and kits.
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HIV Combo Test Gets CE Mark
Ortho’s fourth-generation assay is designed to detect both human immunodeficiency virus 1 and 2 antibodies and the p24 antigen.
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Collaboration to Extend Reach of Infectious Disease Testing Menu
Beckman Coulter Diagnostics will place Ortho-Clinical Diagnostics’ Vitros 3600 systems in very high volume laboratories.
Read MoreTerre Haute Regional Hospital Becomes First to Install Ortho Vision Analyzer
Making the transition from manual to automated blood analysis supports the hospital’s efforts to become a Level II trauma center.
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