BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

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

    Reg #: 3014607865 · FEI: 3014607865 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    35
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    RANDOX LABORATORIES LIMITED
    Registration Number
    3014607865
    FEI Number
    3014607865
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30 RANDALSTOWN ROAD
    City
    ANTRIM, 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 Manufacture Medical Device for Another Party (Contract Manufacturer)