BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IncellMAX C65050

    Reg #: 3008272746 · FEI: 3008272746 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    INCELLDX, INC
    Registration Number
    3008272746
    FEI Number
    3008272746
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30920 Huntwood Avenue
    City
    Hayward
    State
    CA
    ZIP
    94544
    Country
    US

    Owner / Operator

    Firm Name
    IncellDx
    Operator Number
    10031342
    Address
    30920 Huntwood Avenue
    City
    Hayward
    State
    CA
    Postal Code
    94544
    Country
    US
    Correspondent
    Pradeep Kumar

    Products

    Device Name Product Code
    General Purpose Reagent PPM

    Proprietary Names

    IncellMAX C65050 Hybridization Core Reagent 7, 200277 Hybridization Core Reagent 6, 200276 Hybridization Core Reagent 2, 200273 OncoTect iO Control Cells C65010 Hybridization Core Reagent 4, 200275 Hybridization Core Reagent 3, 200274 Hybridization Core Reagent 1, 200272 Cell Cycle Dye C65000 IncellMAX C, C65001 Hybridization Core Reagent F12100

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device