BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit

    Reg #: 2090110 · FEI: 3002346973 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CALBIOTECH, INC.
    Registration Number
    2090110
    FEI Number
    3002346973
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1935 Cordell Ct
    City
    El Cajon
    State
    CA
    ZIP
    92020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K002262

    Owner / Operator

    Firm Name
    Calbiotech, Inc.
    Operator Number
    9046880
    Address
    1935 Cordell Court, --
    City
    El Cajon
    State
    CA
    Postal Code
    92020
    Country
    US
    Correspondent
    DAVID - BARKA

    Products

    Device Name Product Code
    Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific LGC

    Proprietary Names

    Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)