BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fujirebio Diagnostics, Inc.

    Reg #: 2521625 · FEI: 2521625 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    174
    Establishment Types
    3
    Classifications
    20

    Registration Details

    Registration Name
    Fujirebio Diagnostics, Inc.
    Registration Number
    2521625
    FEI Number
    2521625
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    201 Great Valley Parkway
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242706

    Owner / Operator

    Firm Name
    Fujirebio Diagnostics, Inc.
    Operator Number
    10022860
    Address
    201 Great Valley Parkway
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US
    Correspondent
    Greg Dickson

    Products

    Device Name Product Code
    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK
    Enzyme Immunoassay, Methotrexate LAO
    Ovarian Adnexal Mass Assessment Score Test System ONX
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Immunoassay Blood Test For Amyloid Pathology Assessment SET
    Reagent, Coronavirus Serological QKO
    Sirolimus Test System NRP
    Calibrator, Secondary JIT
    Galectin-3 In Vitro Diagnostic Assay OSX
    Enzyme Immunoassay, Tracrolimus MLM
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
    System, Test, Immunological, Antigen, Tumor MOI
    Cytokeratin Fragments 21-1 Eia Kit OVK
    Alzheimer’S Disease Pathology Assessment Test QSE
    System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer NIG
    Test, Epithelial Ovarian Tumor Associated Antigen (He4) OIU
    Calibrators, Drug Specific DLJ
    Cyclosporine MKW
    System, Test, Thyroglobulin MSW
    Test, Natriuretic Peptide NBC

    Proprietary Names

    VITROS CA 125II Calibrators VITROS CA125II Reagent ARCHITECT Methotrexate Reagents (ROW) Alinity i Methotrexate Reagents (ROW) Alinity i Methotrexate Reagents (China) ARCHITECT Methotrexate Reagents (China) ARCHITECT ROMA Alinity i ROMA Lumipulse B-Amyloid Plasma Controls Alinity i Methotrexate Controls (China) NSE [For use with] Alinity i Controls Atellica IM Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens Atellica IM Tumor Marker Quality Controls (TMQC) - Siemens Beckman PK-CMV PA Controls Lumipulse G BRAHMS PCT Controls Lumipulse ? Amyloid Controls Alinity i CYFRA 21-1 Controls (China) Alinity i Methotrexate Controls (ROW) Lumipulse pTau 217 Plasma Controls ARCHITECT Methotrexate Extended Range Controls (ROW) ARCHITECT CYFRA 21-1 Controls Alinity i Methotrexate Extended Range Controls (ROW) ARCHITECT CYFRA 21-1 Controls (China) NSE [For use with] Alinity i Controls (ROW) Alinity i CYFRA 21-1 Controls ADVIA Centaur XPT Tumor Marker Quality Controls (TMQC) - Siemens NSE [For use with] ARCHITECT Controls Alinity i CYFRA 21-1 Controls (ROW) ADVIA Centaur XPT Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens ARCHITECT Methotrexate Extended Range Controls (China) Alinity i Methotrexate Extended Range Controls (China) NSE [For us with] ARCHITECT Controls (ROW) ARCHITECT CYFRA 21-1 Controls (ROW) ARCHITECT Thyroglobulin Controls Alinity i Thyroglobulin Controls Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Lumipulse G B-Amyloid 1-42-N Plasma IC Lumipulse G B-Amyloid 1-42-N Plasma Calibrators Lumipulse G pTau 217 Plasma Calibrators Lumipulse G pTau 217 Plasma IC SARS-CoV-2 IgG assay (for use on ARCHITECT) SARS-CoV-2 IgG assay (for use on Alinity) ARCHITECT Sirolimus Calibrators (China) ARCHITECT Sirolimus Reagents (China) ARCHITECT Sirolimus Reagents ARCHITECT Sirolimus Whole Blood Precipitation Reagent Transplant Pretreatment Tubes 1P06 Alinity i Sirolimus Reagent Kit Alinity i Sirolimus Whole Blood Precipitation Reagent ARCHITECT Sirolimus Calibrators ARCHITECT Sirolimus Controls Alinity i Sirolimus Calibrtors (China) Alinity i Sirolimus Reagents (China) Alinity i Sirolimus Controls ARCHITECT Galectin-3 Reagents, Calibrators and Controls (US) Alinity i Galectin-3 Reagents Alinity i Galectin-3 Calibrators Alinity i Galectin-3 Controls Alinity i Tacrolimus Reagents (China) ARCHITECT Tacrolimus Whole Blood Precipitation Reagent Alinity i Tacrolimus Reagent ARCHITECT Tacrolimus Calibrators Alinity i Tacrolimus Whole Blood Precipitation Reagent ARCHITECT Calibrators (China) ARCHITECT Tacrolimus Reagents (China) Alinity i Tacrolimus Controls ARCHITECT Tacrolimus Alinity i Calibrators (China) VITROS CA15-3 VITROS CA 125 II Calibrator VITROS CA 125 II Reagent Pack VITROS PSA VITROS CA 15-3 Calibrators VITROS CA15-3 Reagent NSE [For use with] ARCHITECT Reagents Alinity i CYFRA 21-1 Reagents (China) ARCHITECT CYFRA 21-1 Reagents NSE [For use with] Alinity i Reagents Alinity i CYFRA 21-1 Reagents ARCHITECT CYFRA 21-1 Reagents (China) Lumipulse G ?-Amyloid Calibrators Lumipulse G ?-Amyloid Ratio (1-42/1-40) Lumipulse G ?-Amyloid Immunoreaction Cartridges 1-42 Lumipulse G ?-Amyloid Immunoreaction Cartridges 1-40 Alinity i CA 19-9XR Calibrators (China) Alinity i CA 19-9XR Reagents Alinity i CA 19-9XR Controls ARCHITECT CA 19-9XR Reagents (China) ARCHITECT CA 19-9XR Controls Alinity i CA 19-9XR Calibrators Alinity i CA 19-9XR Reagents (China) ARCHITECT CA 19-9XR Calibrators ARCHITECT CA 19-9XR Calibrators (China) ARCHITECT CA 19-9XR Reagents ARCHITECT HE4 Calibrators (China) ARCHITECT HE4 Reagents (ROW) ARCHITECT HE4 Controls (China) ARCHITECT HE4 Calibrators (ROW) Alinity i HE4 Calibrators ARCHITECT HE4 Controls (ROW) ARCHITECT HE4 Reagents ARCHITECT HE4 Calibrators ARCHITECT HE4 Controls Alinity i HE4 Controls Alinity i HE4 Reagents (China) Alinity i HE4 Reagents Alinity i HE4 Calibrators (China) Alinity i HE4 Controls (ROW) Alinity i HE4 Controls (China) ARCHITECT HE4 Reagents (China) Alinity i HE4 Reagents (ROW) Alinity i Methotrexate Calibrators (China) ARCHITECT Methotrexate Calibrators (ROW) ARCHITECT CYFRA 21-1 Calibrators (China) Alinity I Thyroglobulin Calibrators NSE [For use with) Alinity i Calibrators (ROW) Alinity i Methotrexate Calibrators (ROW) ARCHITECT Methotrexate Calibrators (China) NSE [For use with) Alinity i Calibrators Alinity i CYFRA 21-1 Calibrators (China) Alinity i CYFRA 21-1 Calibrators (ROW) ARCHITECT Thyroglobulin Calibrators NSE [For use with) ARCHITECT Calibrators ARCHITECT CYFRA 21-1 Calibrators NSE [For use with) ARCHITECT Calibrators (ROW) ARCHITECT CYFRA 21-1 Calibrators (ROW) Alinity i CYFRA 21-1 Calibrators ARCHITECT Cyclosporine Whole Blood Precipitation Reagent ARCHITECT Cyclosporine Calibrators ARCHITECT Cyclosporine Alinity i Cyclosporine Whole Blood Precipitation Reagent Alinity i Cyclosporine Calibrators Alinity i Cyclosporine Reagent Alinity i Thyroglobulin Calibrators Alinity i Thyroglobulin Reagents ARCHITECT Thyroglobulin Reagents Alinity i CA 15-3 Reagents ARCHITECT CA 15-3 Controls Alinity i CA 15-3 Calibrators (China) Alinity i Controls ARCHITECT CA 15-3 Calibrators ARCHITECT CA 15-3 Reagents ARCHITECT CA 15-3 Reagents (China) Alinity i CA 15-3 Reagents (China) Alinity i BNP Controls ARCHITECT BNP-JP Calibrators ARCHITECT BNP Reagents, Calibrators and Controls ARCHITECT BNP Reagents (China) Alinity i BNP Calibrators (China) Alinity i BNP Reagents (China) Alinity i BNP Reagents Alinity i BNP Calibrators ARCHITECT BNP-JP Reagents Alinity i BNP-JP Reagents ARCHITECT BNP Calibrators (China) ARCHITECT BNP-JP Controls VITROS CA 9-9 Calibrators VITROS CA 19-9 Reagent ARCHITECT CA 125II Controls (ROW) Alinity i CA 125II Controls ARCHITECT CA 125II Reagents (China) Alinity i CA 125II Reagents (China) ARCHITECT CA 125II Controls ARCHITECT CA 125II Reagents (ROW) Alinity i CA 125II Calibrators ARCHITECT CA 125II calibrators ARCHITECT CA 125II Calibrators (China) ARCHITECT CA 125II Controls (China) Alinity i CA 125II Reagents (ROW) ARCHITECT CA 125II Reagents Alinity i CA 125II Reagents Alinity i CA 125II Calibrators (China) Alinity i CA 125II Calibrators (ROW) ARCHITECT CA 125II Calibrators (ROW)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only Manufacture Medical Device