BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dimension GGT Flex

    Reg #: 2517506 · FEI: 2517506 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    11

    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
    K861700

    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
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Differential Rate Kinetic Method, Cpk Or Isoenzymes JHS
    Diazo Colorimetry, Bilirubin CIG
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Calibrator, Multi-Analyte Mixture JIX
    Photometric Method, Magnesium JGJ
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Biuret (Colorimetric), Total Protein CEK
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Bromcresol Purple Dye-Binding, Albumin CJW

    Proprietary Names

    Dimension GGT Flex Dimension CHOL Flex Dimension CHOL Cal Dimension CHEM II Cal Dimension ALB Flex Dimension MG Flex

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device