BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OMEGA BIO-TEK

    Reg #: 3014290238 · FEI: 3014290238 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    OMEGA BIO-TEK
    Registration Number
    3014290238
    FEI Number
    3014290238
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    400 Pinnacle Way #450
    City
    Norcross
    State
    GA
    ZIP
    30071
    Country
    US

    Owner / Operator

    Firm Name
    Omega Bio-Tek
    Operator Number
    10090841
    Address
    400 Pinnacle Way #450
    City
    Norcross
    State
    GA
    Postal Code
    30071
    Country
    US

    Products

    Device Name Product Code
    Clinical Sample Concentrator JJH

    Proprietary Names

    MBFit24™ cfDNA Kit CE IVD Mag-Bind® Blood DNA HV Kit CE IVD MBFit24™ Blood & Tissue DNA Kit CE IVD Mag-Bind® Blood & Tissue DNA Kit CE IVD Mag-Bind® Viral DNA/RNA Xpress Kit CE IVD MagBinder Fit24 Mag-Bind® cfDNA Kit CE IVD

    Establishment Types

    Manufacture Device in the United States for Export Only