BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OPI 300 Rapid Urine Test

    Reg #: 3005360469 · FEI: 3005670738 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    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
    K053037

    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
    Enzyme Immunoassay, Opiates DJG

    Proprietary Names

    OPI 300 Rapid Urine Test Acro Biotech Inc. OPI Rapid Urine Test Opiates (OPI) Rapid Test Panel OPI 2000 Rapid Urine Test Opiates (OPI) Rapid Test Cassette Opiates (OPI) Rapid Test Dipstick

    Establishment Types

    Repack or Relabel Medical Device