BEUDAMED
    FDA Registration Active 🇺🇸 United States

    StrepAim Strep A Test

    Reg #: 1649661 · FEI: 3001451797 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GERMAINE LABORATORIES, INC.
    Registration Number
    1649661
    FEI Number
    3001451797
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11030 Wye Drive
    City
    SAN ANTONIO
    State
    TX
    ZIP
    78217
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133343

    Owner / Operator

    Firm Name
    GERMAINE LABORATORIES, INC.
    Operator Number
    9031523
    Address
    11030 Wye Drive
    City
    San Antonio
    State
    TX
    Postal Code
    78217
    Country
    US
    Correspondent
    Craig A Waldrip

    Products

    Device Name Product Code
    Antigens, All Groups, Streptococcus Spp. GTY

    Proprietary Names

    StrepAim Strep A Test

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device