BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    PSA Custom Control Levels 1, 2 and 3, IAC129, IAC130, IAC131

    Reg #: 3004493545 · FEI: 3004493545 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    35
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    RANDOX LABORATORIES LIMITED
    Registration Number
    3004493545
    FEI Number
    3004493545
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    36 / 44 LARGY ROAD
    City
    CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey
    Country
    GB

    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

    US Agent

    Business Name
    RANDOX LABORATORIES-US, LTD
    Contact Name
    Sammy Alnajm
    Address
    515 Industrial Boulevard
    City
    Kearneysville
    State
    WV
    ZIP
    25430
    Country
    US
    Email
    [email protected]
    Phone
    304 7282890

    Products

    Device Name Product Code
    Multi-Analyte Controls Unassayed OHQ

    Proprietary Names

    PSA Custom Control Levels 1, 2 and 3, IAC129, IAC130, IAC131 Apolipoprotein Control Levels 1, 2 and 3 Custom Cardiac Controls Levels 1, 2 and 3, CQ039, CQ040, CQ041 General Chemistry Control Level 1, 2 and 3 Custom Immunassay Control Levels 1,2 and 3, IAC100, IAC101, IAC102 Immunoassay Control Level 1, 2 & 3 LIA5142, LIA5143, LIA5144 Customised Apolipoprotein Control Level 1 and Level 2, LP052/002/CM. LP053/002/CM RANDOX BOVINE PRECISION CONTROLS LIQUID CHEMISTRY PREMIUM - LEVEL 2 (LIQ CHEM PREMIUM 2) HUMAN PRECISION CONTROL - LEVEL 2 (HUM PREC CONTROL 2) LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 1 (LIQ CHEM PREMIUM PLUS 1) LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 2 (LIQ CHEM PREMIUM PLUS 2) RANDOX HUMAN PRECISION CONTROLS RANDOX LIQUID CHEMISTRY PREMIUM PLUS CONTROLS LIQUID CHEMISTRY PREMIUM - LEVEL 3 (LIQ CHEM PREMIUM 3) RANDOX LIQUID CHEMISTRY PREMIUM CONTROLS BOVINE PRECISION MULTI SERA - LEVEL 3 (BOV PREC CONTROL 3) HUMAN PRECISION CONTROL - LEVEL 3 (HUM PREC CONTROL 3) LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 3 (LIQ CHEM PREMIUM PLUS 3) RANDOX BOVINE PRECISION MULTI SERA BOVINE PRECISION MULTI SERA - LEVEL 2 (BOV PREC CONTROL 2) RANDOX PRECISION CHEMISTRY PREMIUM PLUS CONTROLS SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +) SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -) BOVINE PRECISION MULTI SERA - LEVEL 1 (BOV PREC CONTROL 1) SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -) SEROLOGY III POSITIVE CONTROL (SEROLOGY III CONTROL +) SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +) SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +) SEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL +) SEROLOGY ToRCH IgG POSITIVE CONTROL (ToRCH IgG CONTROL +) Randox Liquid Chemistry Premium Plus levels 1,2 and 3 SERUM INDICES (SERUM INDICES) XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA CONTROL -) XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA CONTROL +)

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device