BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QUIDEL CORP.

    Reg #: 2024674 · FEI: 2024674 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    47
    Establishment Types
    3
    Classifications
    23

    Registration Details

    Registration Name
    QUIDEL CORP.
    Registration Number
    2024674
    FEI Number
    2024674
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10165 MCKELLAR CT.
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163713

    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
    Antigens, All Groups, Streptococcus Spp. GTY
    Covid-19 Multi-Analyte Antigen Device QMN
    Reagent, Borrelia Serological Reagent LSR
    Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices QLT
    Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD
    Assayed Quality Control Material For Clinical Microbiology Assays QCH
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG
    Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays PMN
    Real Time Nucleic Acid Amplification System OOI
    Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples PGI
    Visual, Pregnancy Hcg, Prescription Use JHI
    Reagents, Antibody, Legionella, Direct & Indirect Fluorescent LHL
    Antisera, All Groups, Streptococcus Spp. GTZ
    Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings QVF
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Reagent, Occult Blood KHE
    Container, Specimen, Non-Sterile NNI
    Fluorometer, For Clinical Use KHO
    Reagents, Clostridium Difficile Toxin LLH
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Mmp-9 Test System PFQ
    Coronavirus Antigen Detection Test System. QKP
    Campylobacter Spp. LQP

    Proprietary Names

    Sofia S. pneumoniae FIA Sofia 2 Flu + SARS Antigen FIA Sofia Lyme FIA QuickVue Dipstick Strep A Savanna RVP4 Assay QuickVue Adenoviral conjunctivitis Test Sofia 2 Lyme FIA QuickVue RSV Test Savanna HSV 1+2/VZV Control Set Savanna Instrument Savanna HSV 1+2/VZV Assay QuickVue hCG Combo Test Sofia Legionella FIA QuickVue+ Strep A Sofia 2 SARS Antigen+ FIA Control Swab Set Sofia 2 SARS Antigen+ FIA Strep A Liquid Control Set hCG Control Set QuickVue In-Line Strep A Sofia hCG FIA QUICKVUE IFOB TEST QuickVue and Sofia Dry Transport Tubes QuickVue RSV 10 Serum hCG Control Set Sofia 2 Sofia 2 Installation Pack Sofia 2 C. difficile FIA QuickVue Influenza A+B Sofia RSV FIA QuickVue+ hCG Combo Test Savanna RVP Control Set QuickVue In-Line Strep A Ctrl Set Sofia Strep A+ FIA InflammaDry QuickVue hCG Urine Test 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 Installation Pack Sofia Analyzer Sofia Influenza A+B FIA Sofia 2 Campylobacter FIA

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Device in the United States for Export Only