BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRUE LEVEL Instant Drug Test At Home Urine Drug Test Kit

    Reg #: 3013679502 · FEI: 3013679502 · Expires 2025
    View on FDA
    Products
    13
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    13

    Registration Details

    Registration Name
    PREGMATE LLC
    Registration Number
    3013679502
    FEI Number
    3013679502
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3804 N 29th Ave
    City
    Hollywood
    State
    FL
    ZIP
    33020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153050

    Owner / Operator

    Firm Name
    PREGMATE LLC
    Operator Number
    10055200
    Address
    2268 ANCHOR CT
    City
    Fort Lauderdale
    State
    FL
    Postal Code
    33312
    Country
    US
    Correspondent
    VIKTAR MAROZAU

    Products

    Device Name Product Code
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Propoxyphene JXN
    Gas Chromatography, Methamphetamine LAF
    Enzyme Immunoassay, Methadone DJR
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Opiates DJG
    Thin Layer Chromatography, Morphine DNK
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Phencyclidine LCM

    Proprietary Names

    TRUE LEVEL Instant Drug Test At Home Urine Drug Test Kit TRUE LEVEL Drug Test TRUE LEVEL Multi-Drug Testing Kit TRUE LEVEL Drug Screen Test Kit Dip Card TRUE LEVEL Instant Drug Test EZ Level Drug Screen Test Kit Dip Card EZ Level Multi-Drug Testing Kit Checkmate 6 Panel Urine Drug Test Kit EZ Level Instant Drug Test EZ Level Drug Test EZ Level At Home Urine Drug Test Kit EZ Level Instant Drug Test At Home Urine Drug Test Kit Checkmate 12 Panel Urine Drug Test Kit

    Establishment Types

    Repack or Relabel Medical Device