BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RANDOX LABORATORIES-US, LTD

    Reg #: 2086993 · FEI: 3003059701 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    RANDOX LABORATORIES-US, LTD
    Registration Number
    2086993
    FEI Number
    3003059701
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    515 INDUSTRIAL BOULEVARD, JEFFERSON COUNTY
    City
    Kearneysville
    State
    WV
    ZIP
    25430
    Country
    US

    Owner / Operator

    Firm Name
    RANDOX LABORATORIES, LTD.
    Operator Number
    8020890
    Address
    55 DIAMOND RD., --
    City
    CRUMLIN, CO.ANTRIM
    State
    GB-NOTA
    Postal Code
    BT29 4QY
    Country
    GB
    Correspondent
    Karena - Shaw

    Products

    Device Name Product Code
    Blood Specimen Collection Convenience Kit (Excludes Hiv) PQD
    Urine Collection Kit (Excludes Hiv Testing) OIE

    Proprietary Names

    ESSENTIAL PACKAGE SAMPLE COLLECTION KIT (USA) ConcizuTrace™ Sample Collection Kit EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA) EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA U60) BASELINE Venous Sample Collection Kit BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit MALE HORMONE Premium Home Blood Sampling Collection Kit BIOHACKER Premium Home Blood Sampling Collection Kit FEMALE HORMONE Premium Home Blood Sampling Collection Kit PlaySafe™

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device