BEUDAMED
    FDA Registration Active 🇺🇸 United States

    S. pneumo

    Reg #: 3031977134 · FEI: 3031977134 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    bioMerieux, Inc.
    Registration Number
    3031977134
    FEI Number
    3031977134
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3015 Carrington Mill Blvd
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063492

    Owner / Operator

    Firm Name
    BIOMERIEUX SA
    Operator Number
    8020790
    Address
    Chemin De L Orme
    City
    Marcy L Etoile
    State
    Rhone
    Postal Code
    69280
    Country
    FR

    Products

    Device Name Product Code
    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation LON

    Proprietary Names

    S. pneumo VITEK 2 GP Erythromycin for

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198