BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CYTOVALE, INC.

    Reg #: 3017448032 · FEI: 3017448032 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    CYTOVALE, INC.
    Registration Number
    3017448032
    FEI Number
    3017448032
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2 Tower Pl Fl 18
    City
    South San Francisco
    State
    CA
    ZIP
    94080
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250912

    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
    Mixture, Hematology Quality Control JPK

    Proprietary Names

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

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198