BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IML 2000 Toxoplasma Quant IgG

    Reg #: 2517506 · FEI: 2517506 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Registration Number
    2517506
    FEI Number
    2517506
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    500 GBC DR, PO Box 6101
    City
    NEWARK
    State
    DE
    ZIP
    19714
    Country
    US

    Regulatory Submissions

    510(k) Number
    K970227

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US
    Correspondent
    Mary Seeger

    Products

    Device Name Product Code
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Radioimmunoassay, Immunoglobulins (D, E) JHR
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    System, Test, Radioallergosorbent (Rast) Immunological DHB
    Enzyme Immunoassay, Theophylline KLS

    Proprietary Names

    IML 2000 Toxoplasma Quant IgG Chemiluminescent Substrate Module IML 2000 Theophylline IML 2500 Phenobarbital IML 2000 FSH IML 2500 Rubella Quant IgG Sample Management System/VersaCell IML 2500 AlaTOP Probe Cleaning Kit IMMULITE 2000 System IML 2000 3rd Gen TSH IML 2000 AlaTOP IML 2000 Rubella Quant IgG IML 2000 Phenobarbital Probe Wash IML 2500 FSH IML 2500 Toxoplasma Quant IgG IML 2500 Theoplylline IMMULITE 2000 Chemiluminescent Substrate Module IML 2500 3rd Gen TSH VersaCell X3 Solution IMMULITE 2000 XPi Immunoassay System IMMULITE 2000 Immunoassay System IMMULITE 2000 Systems Allergen Tube Caps IMMULITE 2000 Systems Microsampling Tube Caps IMMULITE 2000 Systems Microsampling Tubes IMMULITE 2000 XPi Nesting Cups 1mL IMMULITE 2000 Systems Diluent Tube Caps IMMULITE 2000 Systems Reaction Tubes IMMULITE 2000 XPi Nesting Cups 2mL IMMULITE 2000 Systems Diluent Tubes IMMULITE 2000 Systems Allergen Tubes

    Establishment Types

    Manufacture Medical Device