BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Elite InGenius

    Reg #: 3005748564 · FEI: 3005748564 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PRECISION SYSTEM SCIENCE COMPANY LIMITED
    Registration Number
    3005748564
    FEI Number
    3005748564
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    88 Kamihongou
    City
    Matsudo-city Chiba
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K180559

    Owner / Operator

    Firm Name
    PRECISION SYSTEM SCIENCE COMPANY LIMITED
    Operator Number
    10027605
    Address
    88 Kamihongou
    City
    Matsudo-shi
    State
    Chiba
    Postal Code
    271-0064
    Country
    JP

    US Agent

    Business Name
    Jataki Company LLC
    Contact Name
    Derek Wessman
    Address
    88 W Lake View Terrace Rd
    City
    Saratoga Springs
    State
    UT
    ZIP
    84045
    Country
    US
    Email
    [email protected]
    Phone
    801 6569278

    Products

    Device Name Product Code
    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 Waste Box Elite InGenius SP 200

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)