BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cytoscan Dx Assay Kit

    Reg #: 3003335080 · FEI: 3003335080 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Life Technologies Corporation
    Registration Number
    3003335080
    FEI Number
    3003335080
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7335 Executive Way
    City
    FREDERICK
    State
    MD
    ZIP
    21704
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN130018

    Owner / Operator

    Firm Name
    Life Technologies Corporation
    Operator Number
    9915045
    Address
    5781 Van Allen Way, --
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US

    Products

    Device Name Product Code
    System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection PFX

    Proprietary Names

    Cytoscan Dx Assay Kit CytoScan Dx Pre-PCR -20 C, MOD T E W CytoScan Dx WS B Cytoscan Dx Pre-PCR -20 C, MOD R L A CytoScan Dx Array CytoScan Dx Post-PCR 2-8 C, MOD S AH W PB CytoScan Dx WS A CytoScan Dx Post-PCR -20 C, MOD F L H CytoScan Dx Post-PCR 15-30 C, MOD E PW

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)