BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Selux AST System - GP Panel

    Reg #: 3014474439 · FEI: 3014474439 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    SELUX DIAGNOSTICS
    Registration Number
    3014474439
    FEI Number
    3014474439
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    56 Roland St., Suite 206
    City
    Charlestown
    State
    MA
    ZIP
    02129
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211759

    Owner / Operator

    Firm Name
    Selux Diagnostics
    Operator Number
    10090447
    Address
    56 Roland St., Suite 206
    City
    Charlestown
    State
    MA
    Postal Code
    02129
    Country
    US
    Correspondent
    Liz Kinnal

    Products

    Device Name Product Code
    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation LON
    Susceptibility Test Cards, Antimicrobial LTW
    Panels, Test, Susceptibility, Antimicrobial LTT

    Proprietary Names

    Selux AST System - GP Panel

    Establishment Types

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