BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SafeCup III 13-F

    Reg #: 1649661 · FEI: 3001451797 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    11

    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
    K243365

    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
    Test, Benzodiazepine, Over The Counter NFV
    Test, Methamphetamine, Over The Counter NGG
    Test, Opiates, Over The Counter NGL
    Test, Propoxyphene, Over The Counter QBF
    Test, Methadone, Over The Counter PTG
    Test, Cannabinoid, Over The Counter NFW
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Barbiturate, Over The Counter PTH
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Amphetamine, Over The Counter NFT

    Proprietary Names

    SafeCup III 13-F

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device