Home >> Tag Archives: Ortho Clinical Diagnostics—

Tag Archives: Ortho Clinical Diagnostics—

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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Ortho’s Vitros ALTV Slides

Dec. 26, 2017—Ortho Clinical Diagnostics announced the launch of Vitros ALTV Slides, a new and novel method for the measurement of alanine aminotransferase, a key liver function enzyme found in serum and plasma, using dry slide technology. By using dry slide technology, Vitros ALTV Slides confer several operational and clinical advantages for the clinical laboratory and physicians, including low patient ...

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Vitros HIV Combo gets PMA approval

Dec. 15, 2017—Ortho Clinical Diagnostics has received premarket approval from the FDA for its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (Vitros HIV Combo Test). The Vitros HIV Combo, a fourth-generation assay, is designed to detect both HIV-1 and HIV-2 antibodies and the p24 antigen. The assay is for use on the Vitros 3600 immunodiagnostic system. More top ...

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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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