BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DrugConfirm Urine Drug Test Kits

    Reg #: 3006048451 · FEI: 3006048451 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    Confirm Biosciences LLC
    Registration Number
    3006048451
    FEI Number
    3006048451
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8866 Cypress Court, Building E
    City
    SAN DIEGO
    State
    CA
    ZIP
    92154
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191841

    Owner / Operator

    Firm Name
    Confirm Biosciences LLC
    Operator Number
    9095540
    Address
    8866 Cypress Court, Building E
    City
    San Diego
    State
    CA
    Postal Code
    92154
    Country
    US
    Correspondent
    Albert - Berger

    Products

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

    Proprietary Names

    DrugConfirm Urine Drug Test Kits

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device