BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Acro Single Drug Home Rapid Test Dipstick

    Reg #: 3005360469 · FEI: 3005670738 · Expires 2025
    View on FDA
    Products
    23
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    23

    Registration Details

    Registration Name
    ACRO BIOTECH Inc.
    Registration Number
    3005360469
    FEI Number
    3005670738
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4650 Arrow Hwy Suite D6
    City
    Montclair
    State
    CA
    ZIP
    91763
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182738

    Owner / Operator

    Firm Name
    Acro Biotech Inc.
    Operator Number
    10043465
    Address
    4650 Arrow Hwy Suite D6
    City
    Montclair
    State
    CA
    Postal Code
    91763
    Country
    US
    Correspondent
    Joseph Fan

    Products

    Device Name Product Code
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Gas Chromatography, Methamphetamine LAF
    Test, Morphine, Over The Counter NGI
    Enzyme Immunoassay, Methadone DJR
    Test, Opiates, Over The Counter NGL
    Test, Methadone, Over The Counter PTG
    Test, Cannabinoid, Over The Counter NFW
    Test, Benzodiazepine, Over The Counter NFV
    Enzyme Immunoassay, Barbiturate DIS
    Test, Methamphetamine, Over The Counter NGG
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Benzodiazepine JXM
    Test, Amphetamine, Over The Counter NFT
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Cannabinoids LDJ
    Test, Barbiturate, Over The Counter PTH
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Opiates DJG
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Amphetamine DKZ
    Thin Layer Chromatography, Morphine DNK

    Proprietary Names

    Acro Single Drug Home Rapid Test Dipstick Acro Single and Multi-Drug Rapid Test Cup With Adulteration Acro Single Drug Rapid Test Dipstick Acro Single and Multi-Drug Rapid Test Panel Acro Single and Multi-Drug Home Rapid Test Cup Acro Single and Multi-Drug Home Rapid Test Panel Acro Single and Multi-Drug Rapid Test Panel With Adulteration Acro Single and Multi-Drug Rapid Test Cup

    Establishment Types

    Repack or Relabel Medical Device