BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HPV E6, E7 mRNA Probe_C31100

    Reg #: 3008272746 · FEI: 3008272746 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    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
    Reagents, Specific, Analyte MVU

    Proprietary Names

    HPV E6, E7 mRNA Probe_C31100 Anti CD45 Antibody_U31075 Anti PD-L1 Antibody_C31050 Anti Pan Cytokeratin Antibody Recombinant_U31220 HPV E6, E7 mRNA Probe, Ready to Use_C31315

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device