BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Epidermal Growth Factor Receptor (EGFR) - 31G7 - Mob461A,PDM226A

    Reg #: 3007035884 · FEI: 3007035884 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DIAGNOSTIC BIOSYSTEMS
    Registration Number
    3007035884
    FEI Number
    3007035884
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6616 Owens Drive
    City
    Pleasanton
    State
    CA
    ZIP
    94588
    Country
    US

    Owner / Operator

    Firm Name
    Diagnostic BioSystems
    Operator Number
    10024374
    Address
    6616 Owens Drive
    City
    Pleasanton
    State
    CA
    Postal Code
    94588
    Country
    US
    Correspondent
    Bipin C Gupta

    Products

    Device Name Product Code
    Reagents, Specific, Analyte MVU

    Proprietary Names

    Epidermal Growth Factor Receptor (EGFR) - 31G7 - Mob461A,PDM226A Hepatitis B Surface Antigen, HBsAg (3E7) - Mob125A,PDM079A Epstein-Barr Virus (EBV) - Mob194A,PDM128A Herpesvirus 8 (HHV8) - Mob395A,PDM395A p504S/?-Methylacyl-CoA Racemase (AMACR) - RP134A,PDR046A CMV Cocktail - Mob049A,PDM075A Herpes Simplex Virus Type II (HSV2) - Mob542A,PDM542A Pneumocystis Carinii - Mob091A Adenovirus - Mob355A HSV Cocktail - PDRM001A HLA-DR - Mob069A,PDM082A Herpes Simplex Virus Type I (HSV1) - RP018A,PDR032A HBsAg (3E7) - Mob125A,PDM079A Human Papilloma Virus Type 16, HPV 16 - Mob394A,PDM166A Epidermal Growth Factor Receptor (EGFR) - 111.6 - Mob267A,PDM132A

    Establishment Types

    Manufacture Medical Device