BEUDAMED
    FDA Registration Active 🇱🇹 Lithuania

    SeqStudio™ 24 Flex Dx Genetic Analyzer

    Reg #: 3009573214 · FEI: 3009573214 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    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
    BK110039

    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
    Dna Genetic Analyzer PCA

    Proprietary Names

    SeqStudio™ 24 Flex Dx Genetic Analyzer 3500 Dx Capillary Array 50 cm POP-6™ (384) Performance Optimized Polymer 3500 Dx Series 3500 Dx Series Data Collection Software 3 IVD v3.2 3500xL Dx Capillary Array 50 cm 3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set 3500xL Dx Genetic Analyzer 3500 Dx Series 96-Well Standard Retainer & Base Set 3500 Dx Series Septa Cathode Buffer Container POP-6™ (960) Performance Optimized Polymer 3500 Dx Series 3500 Dx Series Polymer Pouch Caps GeneScan™ 600 LIZ™ Size Standard v2 - Dx Cathode Buffer Container 3500 Dx Series DS-33 Matrix Standard (Dye Set G5) - Dx POP-7™ (384) Performance Optimized Polymer 3500 Dx Series 3500 Dx Series Septa 96-Well POP-7™ (960) Performance Optimized Polymer 3500 Dx Series 3500 Dx Genetic Analyzer Conditioning Reagent 3500 Dx Series Hi-Di™ Formamide 3500 Dx Series DS-30 Matrix Standard Kit (Dye Set D) - Dx Pump Cleaning Kit 3500 Dx Series Sequencing Standard v1.1 3500 Dx Series Anode Buffer Container 3500 Dx Series Sequencing Standard BigDyeTM Terminator V1.1-Dx SeqStudio™ 8 Flex Dx Genetic Analyzer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)