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    FDA Registration Active 🇺🇸 United States

    Dimension Vista® Empty Flex® reagent cartridge

    Reg #: 2517506 · FEI: 2517506 · Expires 2025
    View on FDA
    Products
    15
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    15

    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
    K051087

    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
    Radioimmunoassay, Luteinizing Hormone CEP
    Calibrator, Multi-Analyte Mixture JIX
    Colorimetric Method, Cpk Or Isoenzymes JHY
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Calibrator, Secondary JIT
    Radioimmunoassay, Immunoglobulins (G, A, M) CFQ
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion Specific, Potassium CEM
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Radioimmunoassay, Prolactin (Lactogen) CFT
    Enzyme Immunoassay, Phenobarbital DLZ

    Proprietary Names

    Dimension Vista® Empty Flex® reagent cartridge Dimension Vista® Small Sample Container (SSC) V-Lyte Standard B Dimension Vista® CHK Flex® reagent cartridge V-Lyte Diluent Dimension Vista® Empty Vials Kit Dimension Vista® Mass CKMB Isoenzyme Calibrator Dimension Vista® Aliquot Plates V-Lyte Dilution Check Dimension Vista® Barcode Labels Dimension Vista® Cuvettes Dimension Vista® System Diluent Dimension Vista® Urea Nitrogen Flex® reagent cartridge Dimension Vista® System (500, 1000T, 3000T) V-Lyte Standard A Dimension Vista® Phenobarbital Flex® reagent cartridge Dimension Vista® Sample Probe Cleaner Dimension Vista® Cuvette Wash Solution Dimension Vista® LOCI Reaction Vessels V-Lyte Integrated Multisensor Dimension Vista® Reagent Probe Cleaner Dimension Vista® Sample Cups

    Establishment Types

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