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QuidelOrtho: In pursuit of better health outcomes

Born from the exceptional legacies of Quidel and Ortho Clinical Diagnostics, the QuidelOrtho union in 2022 was more than just a simple merger – it was a fusion of shared visions and unmatched expertise.

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QuidelOrtho has come together to shape the future of in-vitro diagnostics, uniting strengths to offer unparalleled service and innovation.

The QuidelOrtho merger is a testament to a shared commitment to furthering diagnostic precision, ensuring better patient outcomes, and leading the world towards a healthier tomorrow.

We embrace intelligence to illuminate the path forward

We are driven to transform diagnostic data into answers, understanding and action.

We harness the power of diagnostics to improve lives

We proudly continue our legacy of innovation, with industry-leading expertise in immunoassay and molecular testing and award-winning solutions in clinical labs and transfusion medicine.


Meet the family

You’ve probably met a few of us, but you might not know us all. With a shared talent for diagnostic speed and accuracy, as well as a common belief system of service, loyalty and care, we bring diagnostic insights to more places – even yours.

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Point-of-Care-Testing

A continuum of diagnostic immunoassays including visually read rapid lateral flow tests and analyzer read fluorescent immunoassays that interpret and display results. The point-of-care assays accommodate the needs of differing healthcare settings from the physician office to emergency department, from hospital bedside to the laboratory.

Assays include:

• High Sensitivity Troponin I
• Cardiac Marker Panels
• TOX Drug Screens
• Influenza & SARS
• C.difficile
• Camplyobactor
• Many more assays

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Clinical Chemistry

VITROS Solutions, from standalone chemistry and immunoassay systems to integrated systems and fully automated solutions, that deliver consistently fast, accurate and reliable results that expedite treatment decisions and improve patient care. Our proprietary dry chemistry technology enables a long performance and calibration stability, providing precise and accurate results without the need for water.

• Integrated systems
• Immunoassay
• Automation solutions

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Immunohematology

We share the vital mission of donor testing center’s and pre-transfusion labs to enable the reliable and timely access to safe blood products for patients everyday. Blood bank solutions for donor testing and pre-transfusion screening to improve your lab efficiency, workflow and output.

• OrthoVision automated solutions
• Semi-automated solutions
• Comprehensive assay menu for pre-transfusion testing
• Workflow management solutions
• Vitros immunodiagnostics for infectious disease testing

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Over the years

2020s

2025

Launches QuidelOrtho® Results Manager System, strengthening informatics capabilities across the diagnostics portfolio to address the growing demands of modern laboratories

2024

Receives FDA 510(k) clearance for the QuickVue® COVID-19 Test for at-home testing

2023

QuidelOrtho Receives CLIA Waiver for Sofia® 2 SARS Antigen+ FIA

QuidelOrtho Receives De Novo FDA Authorization for Sofia® 2 SARS-CoV-2 Antigen+ FIA

 

QuidelOrtho Receives De Novo Classification for two SARS-CoV-2 Antibody tests: VITROS® Immunodiagnostics Products Anti-SARS-CoV-2 Total Test and VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG test

2022

Health Canada Grants License for Quidel® TriageTrue® High-Sensitivity Troponin l Test to Aid in the Diagnosis of Myocardial Infarction

Quidel Corporation and Ortho Clinical Diagnostics unite as QuidelOrtho with an 80-year history of innovation

 

2021

Quidel recieves FDA EUA for QuickVue® At-Home OTC COVID-19 Test

Ortho begins trading on Nasdaq under the symbol OCDX

2020

Quidel recieves FDA EUA for Sofia® 2 SARS Antigen FIA, the first rapid antigen test for COVID-19

Ortho launches two VITROS® SARS-CoV-2 antibody tests, receiving CE Marks and among the first FDA EUAs for high-volume COVID-19 testing; SARS-CoV-2 antigen test follows in 2021

2010s

2017

Quidel acquires Triage® cardiac and toxicology product line

2016

Ortho receives FDA clearance for Ortho Vision®

2015

Ortho receives FDA clearance for VITROS® automated solutions 

2014

The Carlyle Group acquires Ortho Clinical Diagnostics from Johnson & Johnson

2013

Ortho launches Ortho® Workstation

2011

Quidel receives FDA clearance for Sofia®

2010

Quidel acquires Diagnostic Hybrids, Inc.

2000s

2003

Ortho launches Ortho ProVue®, the first fully automated immunohematology sytem for use with the ID-Micro Typing SystemTM (ID-MTS) Gel Test in North America

2000

Ortho receives first FDA approval for automated random access VITROS® ECiQ Immunodiagnostic System.

1990s

1999

Quidel receives FDA clearance for world's first rapid diagnostics flu test, QuickVue® Influenza Test A+B

1998

Ortho introduces Ortho SummitTM, the first truly automated blood and plasma screening system in the U.S.

1997

Ortho Clinical Diagnostics is formed following the 1994 Johnson & Johnson acquisition of Kodak's diagnostics business

1991

Quidel begins trading on Nasdaq under the symbol QDEL

1980s

1989

Ortho introduces the first hepatitis C antibody test

1985

Quidel receives FDA clearance for Strep A testing

1983

Quidel introduces the first commerical product for pregnancy testing

1970s

1979

Quidel Corporation is founded in San Diego, CA

1978

Kodak Clinical Diagnositics introduces patented thin-film dry slide technology

1940s

1947

Ortho develops the first blood bank anti-D test for the clinical market

1930s

1939

Ortho Products, Inc. is formed in Linden, N.J. as a divison of Johnson & Johnson

Service and Support

Ensuring reliability and efficiency after installation isn't an afterthought – it's a central tenet of our ethos. Recognised with global awards, QuidelOrtho’s steadfast commitment ensures that laboratories can operate seamlessly. In the critical landscape of diagnostics, where every test result has profound implications, we have positioned ourselves as champions of unwavering quality and continuity.

Amidst a world of rapidly evolving technology, we understand the importance of continuous support. Laboratories and clinics depend on knowing that QuidelOrtho is by their side, enabling them to serve patients with timely, accurate results remains unfaltering.


Global Leaders in Diagnostic Excellence

Embrace a partnership that merges legacy with innovation, guiding healthcare forward. To learn more about QuidelOrtho and their life-saving products, simply complete our online contact form, and let's embark on a new era of excellence in diagnostics.