BEUDAMED
    FDA Registration Active 🇱🇹 Lithuania

    Cytoscan Dx Assay Kit

    Reg #: 3009573214 · FEI: 3009573214 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Thermo Fisher Scientific Baltics UAB
    Registration Number
    3009573214
    FEI Number
    3009573214
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    V. A. Graiciuno G. 8
    City
    Vilnius Salcininkai
    Country
    LT

    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)