BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Elite InGenius

    Reg #: 3011461582 · FEI: 3011461582 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ELITechGroup S.p.A.
    Registration Number
    3011461582
    FEI Number
    3011461582
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Corso Svizzera 185
    City
    Torino Piedmont
    Country
    IT

    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

    US Agent

    Business Name
    ELITechGroup Inc.
    Contact Name
    Robert Ortiz
    Address
    370 W 1700 S
    City
    Logan
    State
    UT
    ZIP
    84321
    Country
    US
    Email
    [email protected]
    Phone
    435 7526011 ext. 1465

    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 InGenius Elite InGenius PCR Cassette Elite InGenius SP 200 Consumable Elite InGenius SP 200 Elite InGenius Waste Box

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility