BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TETRACORE, INC

    Reg #: 3003517954 · FEI: 3003517954 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TETRACORE, INC
    Registration Number
    3003517954
    FEI Number
    3003517954
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    77 Upper Rock Circle, SUITE 600
    City
    Potomac
    State
    MD
    ZIP
    20850
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030370

    Owner / Operator

    Firm Name
    TETRACORE, INC
    Operator Number
    9060889
    Address
    77 Upper Rock Circle, SUITE 600
    City
    Rockville
    State
    MD
    Postal Code
    20850
    Country
    US
    Correspondent
    Colleen Lint

    Products

    Device Name Product Code
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody NPO

    Proprietary Names

    EZ-SARS-CoV-2 Real-Time RT-PCR REDLINE ALERT TEST

    Establishment Types

    Manufacture Medical Device