BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

    Reg #: 3007208259 · FEI: 3007208259 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GOLD STANDARD DIAGNOSTICS, LLC
    Registration Number
    3007208259
    FEI Number
    3007208259
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2795 2nd St Ste 300
    City
    Davis
    State
    CA
    ZIP
    95618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150358

    Owner / Operator

    Firm Name
    Gold Standard Diagnostics
    Operator Number
    10025460
    Address
    2795 2nd Street, Suite 300
    City
    Davis
    State
    CA
    Postal Code
    95618
    Country
    US

    Products

    Device Name Product Code
    Antigens, Nontreponemal, All GMQ

    Proprietary Names

    Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device