Our story
QuidelOrtho stands at the forefront of testing, tracking, and disease analysis of health conditions ranging from HIV and hepatitis C to flu, strep and COVID-19. For decades, our precision and accuracy have guided clinicians and lab technicians in the moments that matter most.
By uniting the power of Quidel Corporation and Ortho Clinical Diagnostics, QuidelOrtho serves the entire healthcare continuum: from high-volume, high-complexity hospitals and labs to point-of-care, retail and over-the-counter markets. This enables us to continue our legacy of diagnostics in an ever-changing environment where we're passionately pursuing the unknown to advance diagnostic science and care.
A history of firsts
Over the years
2020s
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
