Dec. 27, 2021—Quidel and Ortho Clinical Diagnostics have entered into a definitive agreement in which Quidel will acquire Ortho for $24.68 per share of common stock for a total consideration of about $6.0 billion.
Read More »FDA authorizes Ortho quantitative serology test
September 2021—The FDA issued an emergency use authorization to Ortho Clinical Diagnostics for its Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative test.
Read More »FDA authorizes first quantitative serology test
July 9, 2021—Today the FDA issued an emergency use authorization to Ortho Clinical Diagnostics for the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative test.
Read More »CE-marked Ortho COVID-19 total antibody test
June 2020—Ortho Clinical Diagnostics announced its COVID-19 total antibody test received the CE mark. The test offers excellent performance, with 100 percent specificity and sensitivity, and detects all COVID-19 related antibodies—IgA, IgM, and IgG.
Read More »Ortho’s COVID-19 IgG antibody test receives CE mark
May 19, 2020—Ortho Clinical Diagnostics announced its second COVID-19 antibody test, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test, received the CE mark. The test offers 100 percent specificity.
Read More »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.
Read More »Ortho’s COVID-19 total antibody test receives CE mark
May 13, 2020—Ortho Clinical Diagnostics announced its COVID-19 total antibody test received the CE mark.
Read More »Ortho launches second COVID-19 antibody test
April 27, 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.
Read More »Ortho Clinical Diagnostics COVID-19 antibody test
April 6, 2020—Ortho Clinical Diagnostics is launching its SARS-CoV-2 antibody test, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack.
Read More »Vitros Brahms PCT, Ortho Sera clearances
March 11, 2020—Ortho Clinical Diagnostics announced its Ortho Sera antigen blood phenotyping for patients in need of transfusions has been cleared to run on the Ortho Visionplatformin the United States and Canada.
Read More »Ortho Clinical launches Vitros XT 3400 chemistry system
Feb. 28, 2020—Ortho Clinical Diagnostics launched the Vitros XT 3400 chemistry system, completing the suite of the company’s Vitros XT Solutions, which includes the Vitros XT 7600 integrated system and new XT MicroSlides.
Read More »Ortho Clinical expands testing menu
December 2019—Ortho Clinical Diagnostics, in collaboration with Thermo Fisher Scientific, has expanded the menu on MicroTip-capable Vitros systems to enable testing for fentanyl and tricyclic antidepressants.
Read More »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.
Read More »FDA clears Ortho Clinical Vitros XT MicroSlides
June 2019—Ortho Clinical Diagnostics’ Vitros XT MicroSlides have been cleared by the FDA. The product features multitest technology that allows laboratories to run two tests simultaneously on one MicroSlide.
Read More »Ortho Clinical, Leadman introduce assays in China
April 2019—Ortho Clinical Diagnostics, in collaboration with Beijing Leadman Biochemistry, launched four MicroTip partnership assays in China. The assays, for renal, liver, and cardiac testing, include cystatin C, α-hydroxybutyrate dehydrogenase, homocysteine, and total bile acid.
Read More »FDA clears Ortho’s Vitros XT MicroSlides
April 11, 2019–Ortho Clinical Diagnostics’ Vitros XT MicroSlides have been cleared by the FDA. The product features multitest technology that allows laboratories to run two tests simultaneously on one MicroSlide.
Read More »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.
Read More »FDA OKs Vitros HIV Combo on Vitros 5600
January 2019—Ortho Clinical Diagnostics’ Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator received FDA approval for use on Ortho’s Vitros 5600 Integrated System.
Read More »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 ...
Read More »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 ...
Read More »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 ...
Read More »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.
Read More »Ortho Vitros ALTV Slides, 3/18
March 2018—Ortho Clinical Diagnostics launched its Vitros ALTV Slides for the measurement of alanine aminotransferase, a key liver function enzyme found in serum and plasma, using dry slide technology.
Read More »Ortho, EKF collaborate on BHB assay, 2/18
February 2018—Ortho Clinical Diagnostics and EKF Diagnostics announced an agreement that allows Ortho customers to access EKF’s Beta-Hydroxybutyrate LiquiColor Assay, a CLIA moderate-complexity test for use on Ortho’s Vitros 4600 Chemistry System and Vitros 5600 Integrated System.
Read More »FDA-approved Ortho hepatitis B assays, 11/17
November 2017—Ortho Clinical Diagnostics received FDA approval for the Vitros Immunodiagnostic Products HBeAg Assay and the Vitros Anti-HBe Assay for use on the Vitros 3600 Immunodiagnostic System and 5600 Integrated System.
Read More »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.
Read More »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.
Read More »Vitros NephroCheck test for AKI gets CE mark, 8/17
August 2017—Ortho Clinical Diagnostics launched its Vitros NephroCheck test, a fully automated risk assessment tool for predicting acute kidney injury. The test has received CE mark clearance and is available for purchase in Europe and for use on Ortho’s Vitros Systems.
Read More »PMA application submitted for Vitros HIV Combo, 3/17
March 2017—Ortho Clinical Diagnostics has submitted a premarket approval application to the U.S. Food and Drug Administration for the Vitros Immunodiagnostic Products HIV Combo Assay for use on the Vitros 3600 immunodiagnostic system.
Read More »FDA clears Vitros automation solutions, 1/17
January 2017—Ortho Clinical Diagnostics announced that the Food and Drug Administration has cleared its Vitros Automation Solutions for use with Ortho’s Vitros chemistry, immunodiagnostics, and integrated systems.
Read More »Transfusion medicine instrument, predictive technology, 10/16
October 2016—Products on display in Ortho Clinical’s booth included the company’s flagship Integrated Clinical Chemistry and Immunodiagnostic Systems and the Nephrocheck Test. The Ortho Vision Max transfusion medicine instrument (shown below), which is pending 510(k) clearance, was highlighted as well.
Read More »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.
Read More »Ortho to distribute new Hemo Bioscience products, 11/13
Hemo Bioscience and Ortho Clinical Diagnostics have developed an exclusive arrangement for distribution of two new HBS products.
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