BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ortho-Clinical Diagnostics, Inc.

    Reg #: 3033751096 · FEI: 3033751096 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    44
    Establishment Types
    3
    Classifications
    20

    Registration Details

    Registration Name
    Ortho-Clinical Diagnostics, Inc.
    Registration Number
    3033751096
    FEI Number
    3033751096
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9975 Summers Ridge Rd
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231795

    Owner / Operator

    Firm Name
    QuidelOrtho Corporation
    Operator Number
    2024674
    Address
    9975 Summers Ridge Road
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US

    Products

    Device Name Product Code
    Over-The-Counter Covid-19 Antigen Test QYT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Reagent, Borrelia Serological Reagent LSR
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Fluorometer, For Clinical Use KHO
    Visual, Pregnancy Hcg, Prescription Use JHI
    Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings QVF
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG
    Antigens, All Groups, Streptococcus Spp. GTY
    Assayed Quality Control Material For Clinical Microbiology Assays QCH
    Campylobacter Spp. LQP
    Antisera, All Groups, Streptococcus Spp. GTZ
    Mmp-9 Test System PFQ
    Coronavirus Antigen Detection Test System. QKP
    Reagents, Antibody, Legionella, Direct & Indirect Fluorescent LHL
    Reagents, Clostridium Difficile Toxin LLH
    Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD
    Covid-19 Multi-Analyte Antigen Device QMN
    Reagent, Occult Blood KHE
    Container, Specimen, Non-Sterile NNI

    Proprietary Names

    Walgreens At-Home COVID-19 Test Kit QuickVue COVID-19 Test CVS Health At Home COVID-19 Test Kit hCG Control Set Sofia Lyme FIA Sofia Installation Pack Sofia Analyzer Sofia Influenza A+B FIA QuickVue+ hCG Combo Test Sofia 2 SARS Antigen+ FIA Control Swab Set Sofia 2 SARS Antigen+ FIA Sofia RSV FIA QuickVue In-Line Strep A Ctrl Set Sofia 2 Lyme FIA Sofia 2 Campylobacter FIA Sofia 2 QuickVue hCG Combo Test Strep A Liquid Control Set InflammaDry QuickVue Dipstick Strep A QuickVue hCG Urine Test QuickVue Influenza A+B QuickVue+ Strep A QuickVue At Home COVID-19 Sofia SARS Antigen FIA Sofia 2 SARS Antigen FIA QuickVue SARS Antigen Test VITROS SARS-COV-2 Antigen Reagent Pack EUA202928 VITROS SARS-COV-2 Antigen Calibrator EUA202928 VITROS SARS-COV-2 Antigen Controls EUA202928 VITROS SARS-COV-2 Extraction Buffer EUA202928 Sofia 2 Installation Pack Sofia Legionella FIA Sofia hCG FIA Sofia 2 C. difficile FIA Sofia S. pneumoniae FIA QuickVue RSV Test Sofia Strep A+ FIA QuickVue Adenoviral conjunctivitis Test Sofia 2 Flu + SARS Antigen FIA QuickVue In-Line Strep A QUICKVUE IFOB TEST Serum hCG Control Set QuickVue and Sofia Dry Transport Tubes

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only