BEUDAMED
    FDA Registration Active 🇫🇷 France

    DIAGAST

    Reg #: 3006261638 · FEI: 3006261638 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    DIAGAST
    Registration Number
    3006261638
    FEI Number
    3006261638
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Parc Eurasante, 251, Avenue Eugene Avinee
    City
    LOOS Hauts-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    BK160084

    Owner / Operator

    Firm Name
    DIAGAST
    Operator Number
    10057342
    Address
    Parc Eurasante, 251, Avenue Eugene Avinee
    City
    LOOS
    State
    Hauts-de-France
    Postal Code
    59120
    Country
    FR
    Correspondent
    Laurent KEYSER

    US Agent

    Business Name
    North America Science Associates, Inc
    Contact Name
    Adrian KEENE
    Address
    6750 Wales Rd
    City
    Northwood
    State
    OH
    ZIP
    43619
    Country
    US
    Email
    [email protected]
    Phone
    866 6669455

    Products

    Device Name Product Code
    Media, Potentiating For In Vitro Diagnostic Use KSG
    Kit, Quality Control For Blood Banking Reagents KSF
    Solution, Stabilized Enzyme KSK

    Proprietary Names

    LISS - Low-Ionic-Strength Solution Neg Control PK SYSTEM CONTROL Papain Beckman Coulter Bromelin

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198