BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cytovale Diluent

    Reg #: 3035108302 · FEI: 3035108302 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Cytovale, Inc. (PBRC)
    Registration Number
    3035108302
    FEI Number
    3035108302
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6400 Perkins RD, Lab C-2038.7
    City
    Baton Rouge
    State
    LA
    ZIP
    70808
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220991

    Owner / Operator

    Firm Name
    Cytovale, Inc.
    Operator Number
    10088591
    Address
    2 Tower Place, 18th Floor
    City
    South San Francisco
    State
    CA
    Postal Code
    94080
    Country
    US
    Correspondent
    Sarah Esterquest

    Products

    Device Name Product Code
    Deformability Cytometry For Sepsis Risk Assessment QUT

    Proprietary Names

    Cytovale Diluent Cytovale Cleanse IntelliSep Cartridge Cytovale System Cytovale Reagent Kit IntelliSep test

    Establishment Types

    Manufacture Medical Device