BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ELITe MGB HSV 1&2 Assay

    Reg #: 3003540236 · FEI: 3003540236 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ELITechGroup MDX LLC.
    Registration Number
    3003540236
    FEI Number
    3003540236
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    21720 23rd Dr SE, Suite 150
    City
    Bothell
    State
    WA
    ZIP
    98021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180559

    Owner / Operator

    Firm Name
    ELITechGroup Inc.
    Operator Number
    1717966
    Address
    370 West 1700 South
    City
    Logan
    State
    UT
    Postal Code
    84321
    Country
    US
    Correspondent
    Roberto Ortiz

    Products

    Device Name Product Code
    Real Time Nucleic Acid Amplification System OOI
    Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples PGI

    Proprietary Names

    ELITe MGB HSV 1&2 Assay

    Establishment Types

    Manufacture Medical Device