BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ANA 8 Screen ELISA, EIA-3562

    Reg #: 3002800697 · FEI: 3002800697 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DRG INSTRUMENTS GMBH
    Registration Number
    3002800697
    FEI Number
    3002800697
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    FRAUENBERGSTRASSE 18
    City
    MARBURG Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K030929

    Owner / Operator

    Firm Name
    BIOCHECK, INC.
    Operator Number
    9033543
    Address
    425 Eccles Avenue, --
    City
    South San Francisco
    State
    CA
    Postal Code
    94080
    Country
    US
    Correspondent
    Johanna - Saito

    US Agent

    Business Name
    DRG International, Inc.
    Contact Name
    Ina Hairston
    Address
    841 Mountain Ave
    City
    Springfield
    State
    NJ
    ZIP
    07081
    Country
    US
    Email
    [email protected]
    Phone
    973 5647555 ext. 229

    Products

    Device Name Product Code
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control LRM

    Proprietary Names

    ANA 8 Screen ELISA, EIA-3562 ANACombi (ANA-8-Profile) ELISA, EIA-3563

    Establishment Types

    Repack or Relabel Medical Device