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Data / Medical devices / United States / Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 24 510(k) clearances

Ortho-Clinical Diagnostics, Inc. is registered with the FDA (registration 3021090658) in Carlsbad, CA, United States. It lists 21 device types. The FDA files 24 510(k) clearances under its listings, the newest dated March 22, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Ortho-Clinical Diagnostics, Inc.
FDA registration number
3021090658
Address
2285 Rutherford Road, Carlsbad, CA, United States, 92008
Owner or operator
QuidelOrtho Corporation (2024674)
Roles
Complaint file establishment, Manufacturer, Manufacturer for export
First device listed
December 22, 1992
Registered through
2026
Brand names listed
CVS Health At Home COVID-19 Test Kit, InflammaDry, QUICKVUE IFOB TEST, QuickVue Adenoviral conjunctivitis Test, QuickVue At Home COVID-19, QuickVue COVID-19 Test, QuickVue COVID-19 Test Control Swab Set, QuickVue Dipstick Strep A and more

Devices it lists

DeviceProduct codeClassRoleSource
Antigen, Cf (Including Cf Controls), Respiratory Syncytial VirusGQG1Manufactureraccessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.GTY1Manufactureraccessdata.fda.gov
Antigens, Cf (Including Cf Control), Adenovirus 1-33GOD1Manufactureraccessdata.fda.gov
Antisera, All Groups, Streptococcus Spp.GTZ1Manufactureraccessdata.fda.gov
Assayed Quality Control Material For Clinical Microbiology AssaysQCH2Manufactureraccessdata.fda.gov
Campylobacter Spp.LQP1Manufactureraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Manufactureraccessdata.fda.gov
Coronavirus Antigen Detection Test System.QKPNManufactureraccessdata.fda.gov
Covid-19 Multi-Analyte Antigen DeviceQMNNManufactureraccessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus AntigensPSZ2Manufactureraccessdata.fda.gov
Fluorometer, For Clinical UseKHO1Manufactureraccessdata.fda.gov
Mmp-9 Test SystemPFQ1Manufactureraccessdata.fda.gov
Multi-Analyte Controls UnassayedOHQ1Complaint file establishment, Manufactureraccessdata.fda.gov
Over-The-Counter Covid-19 Antigen TestQYT2Manufactureraccessdata.fda.gov
Reagent, Borrelia Serological ReagentLSR2Manufactureraccessdata.fda.gov
Reagent, Occult BloodKHE2Manufactureraccessdata.fda.gov
Reagents, Antibody, Legionella, Direct & Indirect FluorescentLHL2Manufacturer for exportaccessdata.fda.gov
Reagents, Clostridium Difficile ToxinLLH1Manufacturer for exportaccessdata.fda.gov
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient SettingsQVF2Manufactureraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Manufactureraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 22, 2024K231795QuickVue COVID-19 TestQYTSubstantially EquivalentQuidel Corporationaccessdata.fda.gov
December 13, 2023K233688Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetQVFSubstantially EquivalentQuidel Corporationaccessdata.fda.gov
March 8, 2023DEN220039Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetQVFUnknownQuidel Corporationaccessdata.fda.gov
November 23, 2021K211342Sofia 2 Campylobacter FIALQPSubstantially EquivalentQuidel Corporationaccessdata.fda.gov
August 30, 2018K173496Sofia 2 Lyme FIA, Sofia Lyme Control SetLSRSubstantially EquivalentQuidel Corporationaccessdata.fda.gov
October 20, 2017K163713Sofia Lyme FIA, Sofia Lyme Control SetLSRSubstantially EquivalentQuidel Corporationaccessdata.fda.gov
February 22, 2017K162911Sofia RSV FIA on Sofia 2 analyzerGQGSubstantially EquivalentQuidel Corporationaccessdata.fda.gov
December 16, 2014K141775SOFIA (R) STREP A+ FIAGTYSubstantially EquivalentQuidel Corporationaccessdata.fda.gov
November 21, 2013K132066INFLAMMA DRYPFQSubstantially EquivalentRapid Pathogen Screening, Inc.accessdata.fda.gov
August 13, 2013K130398SOFIA(R) RSV FIAGQGSubstantially EquivalentQuidel Corp.accessdata.fda.gov
October 24, 2011K112177SOFIA ANALYZER AND INFLUENZA A+B FIAPSZSubstantially EquivalentQuidel Corp.accessdata.fda.gov
May 17, 2011K110722RPS ADENO DETECTOR PLUSGODSubstantially EquivalentRapid Pathogen Screening, Inc.accessdata.fda.gov
April 23, 2007K070747QUICK VUE RSV TEST, MODELS 20193, 20199GQGSubstantially EquivalentQuidel Corp.accessdata.fda.gov
December 14, 2005K053146QUICKVUE INFLUENZA A + B TESTPSZSubstantially EquivalentQuidel Corp.accessdata.fda.gov
June 17, 2002K021423INSTANT-VIEW FECAL OCCULT BLOOD RAPID TESTKHESubstantially EquivalentAlfa Scientific Designs, Inc.accessdata.fda.gov
May 17, 2002K020801QUICKVUE ONE-STEP HCG-COMBOJHISubstantially EquivalentQuidel Corp.accessdata.fda.gov
May 17, 2002K020799QUICKVUE ONE-STEP HCG-URINEJHISubstantially EquivalentQuidel Corp.accessdata.fda.gov
May 8, 2001K011097QUICKVUE DIPSTICK STREP AGTYSubstantially EquivalentQuidel Corp.accessdata.fda.gov
November 26, 1997K973858CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBOJHISubstantially EquivalentQuidel Corp.accessdata.fda.gov
April 15, 1996K955108CARDS Q.S. STREP AGTZSubstantially EquivalentQuidel Corp.accessdata.fda.gov
February 10, 1995K945080QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)GTYSubstantially EquivalentQuidel Corp.accessdata.fda.gov
July 18, 1994K934484QUICKVUE IN-LINE ONE-STEP STREP A TESTGTZSubstantially EquivalentQuidel Corp.accessdata.fda.gov
June 22, 1993K931761QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)JJXSubstantially EquivalentQuidel Corp.accessdata.fda.gov
August 7, 1991K912868GROUP A STREP POSITIVE AND NEGATIVE CONTROLSGTZSubstantially EquivalentQuidel Corp.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
January 3, 202493799Class IIOngoingThe Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for tOne lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration accessdata.fda.gov

Compare with other makers

Updated March 22, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.