BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Fujirebio Inc.

    Reg #: 3002895169 · FEI: 3002895169 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    51
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    Fujirebio Inc.
    Registration Number
    3002895169
    FEI Number
    3002895169
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-3-14 Tanashioda, Chuo-ku
    City
    Sagamihara-shi Kanagawa
    Country
    JP

    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

    US Agent

    Business Name
    Fujirebio Diagnostics, Inc.
    Contact Name
    Greg Dickson
    Address
    201 Great Valley Parkway
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    610 2403888

    Products

    Device Name Product Code
    Multi-Analyte Controls Unassayed OHQ
    Immunoassay Blood Test For Amyloid Pathology Assessment SET
    Procalcitonin Assay PRI
    Antigen, Inflammatory Response Marker, Sepsis NTM
    Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens PMT
    Calibrator, Secondary JIT
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK
    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum LIP
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Alzheimer’S Disease Pathology Assessment Test QSE

    Proprietary Names

    Syphilis Control Set Lumipulse Infectious Diseases 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 LUMIPULSE G BRAHMS PCT Calibrator Set LUMIPULSE G BRAHMS PCT IRC Lumipulse G CA125II Calibrators Lumipulse G CA125II IC Lumipulse G Wash Solution 4008248 Lumipulse G1200 Instrument Lumipulse G Wash Solution 231173 Substrate Solutions Lumipulse G Dilution Cartridges Soda Lime for Lumipulse System Specimen Diluent 1 Lumipulse G TP-N Calibrators Lumipulse G TP-N IC 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 ?-Amyloid Calibrators Lumipulse G ?-Amyloid Ratio (1-42/1-40) Lumipulse G ?-Amyloid Immunoreaction Cartridges 1-42 Lumipulse G ?-Amyloid Immunoreaction Cartridges 1-40

    Establishment Types

    Manufacture Medical Device