BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ANA 8 Screen ELISA, EIA-3562

    Reg #: 2245285 · FEI: 2245285 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DRG International, Inc.
    Registration Number
    2245285
    FEI Number
    2245285
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    841 Mountain Ave
    City
    Springfield
    State
    NJ
    ZIP
    07081
    Country
    US

    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

    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