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Tag Archives: Ortho Clinical Diagnostics

Ortho launches second COVID-19 antibody test

May 2020—Ortho Clinical Diagnostics announced the FDA granted emergency use authorization to its second COVID-19 antibody test—the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test. The test demonstrated 100 percent specificity and runs on Ortho’s high-throughput, fully automated analyzers including its Vitros XT 7600 integrated system, Vitros 3600 immunodiagnostic system, Vitros 5600 integrated system, and it will soon be available on Vitros ECi/ECiQ immunodiagnostic systems.

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FDA expands use of Vitros HIV Combo test

September 2019—Ortho Clinical Diagnostics announced that its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (Vitros HIV Combo test) has been granted FDA premarket approval for use on Ortho’s Vitros XT 7600 Integrated System. The Vitros HIV Combo is a fourth-generation test that detects HIV-1 and HIV-2 antibodies and the p24 antigen.

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Ortho launches MicroTip Partnership assays

January 2019—Ortho Clinical Diagnostics is offering three new assays through its MicroTip Partnership Assay program. The company will offer kappa free light chain and lambda free light chain assays in collaboration with Diazyme Laboratories and a methotrexate assay through a collaboration with Ark Diagnostics and Sekisui Diagnostics.

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Vitros HIV Combo test gets expanded approval

Nov. 30, 2018–Ortho Clinical Diagnostics announced that its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator received FDA approval for use on the company’s Vitros ECi/ECiQ Immunodiagnostic Systems. Vitros HIV Combo, a fourth-generation test, detects HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag). “Early detection of HIV-1 is critical in getting patients into treatment as soon as ...

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FDA OKs Vitros HIV Combo on Vitros 5600

Nov. 15, 2018—Ortho Clinical Diagnostics’ Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator received FDA approval for use on Ortho’s Vitros 5600 Integrated System. The Vitros HIV Combo, a fourth-generation test, detects both HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag). “Ortho is committed to expanding its assay menu to meet current guidelines and testing needs,” Jennifer ...

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FDA clears Ortho’s Vitros XT 7600 Integrated System

Nov. 5, 2018—Ortho Clinical Diagnostics received FDA clearance for its Vitros XT 7600 Integrated System. The Vitros XT 7600 uses the company’s Digital Chemistry technology, which combines microslide technology, digital imaging, and dry slide technology. “It’s an exciting time for clinical labs, and today’s clearance of Ortho’s Vitros XT 7600 System represents a fundamental improvement in the way labs can ...

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Ortho Vitros XT 7600 gets CE mark

August 2018—Ortho Clinical Diagnostics received the CE mark for the Ortho Vitros XT 7600 integrated chemistry system. The digital chemistry is based on three technologies: dry slide, microslide, and digital imaging. Dry slide technology does not require water to run, which eliminates the risk of poor water quality affecting test results.

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Vitros insulin assay gets FDA clearance, 10/17

October 2017—Ortho Clinical Diagnostics announced that its Vitros Immunodiagnostic Products Insulin Reagent and Calibrators have received FDA clearance and the CE mark. The assay is expected to be commercially available for use on all of the company’s Vitros immunodiagnostic and integrated systems in Europe, in other countries accepting the CE mark, and in the U.S. during the third quarter of this year.

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Ortho, Brahms agreement, 9/17

September 2017—Ortho Clinical Diagnostics announced a strategic relationship with Brahms GmbH, part of Thermo Fisher Scientific, to develop the Brahms PCT assay for use on Ortho’s Vitros Systems. The Brahms PCT assay is used in conjunction with other laboratory findings and clinical assessment to aid in sepsis management, including early identification of patients at higher risk of progressing to septic shock, identifying when it is safe to discontinue antibiotics, and establishing mortality risk in septic patients.

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510(k) clearance for diabetes testing assay, 8/15

August 2015—The FDA has cleared Ortho-Clinical Diagnostics’ Vitros Chemistry Products HbA1c Reagent Kit for use on the Vitros 5600 Integrated System, Vitros 4600 Chemistry System, and the Vitros 5,1 FS Chemistry System. The test can be used for the quantitative determination of percent glycated hemoglobin A1c and mmol/mol hemoglobin A1c in human whole blood.

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