BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PrimeStore MTM

    Reg #: 3011818318 · FEI: 3011818318 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Longhorn Vaccines and Diagnostics LLC
    Registration Number
    3011818318
    FEI Number
    3011818318
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7272 Wisconsin Avenue, Suite 900
    City
    Bethesda
    State
    MD
    ZIP
    20814
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN170029

    Owner / Operator

    Firm Name
    Longhorn Vaccines and Diagnostics LLC
    Operator Number
    10077988
    Address
    7272 Wisconsin Avenue, Suite 910
    City
    Bethesda
    State
    MD
    Postal Code
    20814
    Country
    US
    Correspondent
    Jeff Fischer

    Products

    Device Name Product Code
    Microbial Nucleic Acid Storage And Stabilization Device QBD

    Proprietary Names

    PrimeStore MTM

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198