BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PFE-39-19-6 Cadherin protein IVD, antibody

    Reg #: 3008363390 · FEI: 3008363390 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EPITOMICS, INC.
    Registration Number
    3008363390
    FEI Number
    3008363390
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    152 Grove Street Building 1100
    City
    Waltham
    State
    MA
    ZIP
    02453
    Country
    US

    Owner / Operator

    Firm Name
    Epitomics, Inc.
    Operator Number
    10032141
    Address
    152 Grove Street Building 1100
    City
    Waltham
    State
    MA
    Postal Code
    02453
    Country
    US
    Correspondent
    Sam Khemici

    Products

    Device Name Product Code
    Reagents, Specific, Analyte MVU

    Proprietary Names

    PFE-39-19-6 Cadherin protein IVD, antibody EP 282 Proto-oncogene tyrosine-protein kinase ROS (ROS1) IVD, antibody EP 93 Topoisomerase IIa IVD, antibody EP28-8 Programmed death-ligand 1 (PD-L1) IVD, antibody EP344 idermal growth factor rector (EGFR) IVD, antibody EP49 MSH6 antigen IVD, antibody EP 415 Programmed death-ligand 1 (PD-L1) IVD, antibody EP3 C-erbB2/Her2/neu oncoprotein IVD, antibody EP51 Postmeiotic segregation increased 2 (PMS2) IVD, antibody EP 279 Helicobacter pylori antigen IVD, antibody EP 271 MDR-1 IVD, Antibody EP1 ER Alpha Estrogen (oestrogen)/progesterone rector IVD, antibody EP220 Estrogen (oestrogen)/progesterone rector IVD, antibody EP2 Progesterone rector IVD, antibody EP10 CD117 (c-kit) cell marker IVD, antibody

    Establishment Types

    Manufacture Medical Device