BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)

    Reg #: 3004493545 · FEI: 3004493545 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    60
    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, All Kinds (Assayed) JJY

    Proprietary Names

    Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3) Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) LIQUID CARDIAC CONTROL 1 LIQUID IMMUNOASSAY CONTROL - LEVEL 1 (IA CONTROL 1) APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1) COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3) COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM – LEVEL 2 (LIQ CHEM ASY PREMIUM 2) LIQUID FROZEN LIPID CONTROL - LEVEL 1 (LIQ LPD CONTROL 1) ASSAYED BOVINE MULTI SERA - LEVEL 2 (BOV ASY CONTROL 2) CHEMISTRY PREMIUM - LEVEL 3 (CHEM PREMIUM 3) CHEMISTRY PREMIUM - LEVEL 2 (CHEM PREMIUM 2) APOLIPOPROTEIN CONTROL - LEVEL 2 (APO CONTROL 2) BILIRUBIN ELEVATED SERUM (BIL CONTROL H) LIQUID BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1) LIQUID FROZEN LIPID CONTROL - LEVEL 2 (LIQ LPD CONTROL 2) APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R) RANDOX SERUM DILUENT (DIL SM) LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM – LEVEL 3 (LIQ CHEM ASY PREMIUM 3) ASSAYED BOVINE MULTI SERA - LEVEL 1 (BOV ASY CONTROL 1) SPECIFIC PROTEIN CONTROL - LEVEL 1 (SP CONTROL 1) ESOTERIC LINEARITY VERIFIERS (For Roche Systems) (ESOTERIC LIN VER ROCHE) LIQUID CSF CONTROL - LEVEL 1 (CSF CONTROL 1) SPECIFIC PROTEIN CONTROL - LEVEL 2 (SP CONTROL 2) LIQUID FROZEN LIPID CONTROL - LEVEL 3 (LIQ LPD CONTROL 3) LIQUID CSF CONTROL - LEVEL 2 (CSF CONTROL 2) CLINICAL CHEMISTRY LINEARITY VERIFIERS (For Roche Systems) (LIQ CLIN CHEM LIN VER) ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3) SPECIFIC PROTEIN CONTROL - LEVEL 3 (SP CONTROL 3) APOLIPOPROTEIN CONTROL - LEVEL 3 (APO CONTROL 3) COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2) LIQUID BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2) BILIRUBIN LINEARITY VERIFIER (For Roche Systems) (BILIRUBIN LIN VER ROCHE) CO2/ELECTROLYTE LINEARITY VERIFIERS (For Roche Systems) (CO2 LIN VER) LIPID LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Lipid LinVer - BC) ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE) LIPID LINEARITY VERIFIERS (For Roche Systems) (LLV-R) APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Apo LinVer - BC) LIAISON Endocrinology Calibration Verifiers CYTOKINE CONTROL CARDIAC CONTROL - LEVEL 3 (CRD CONTROL 3) CYTOKINE HIGH SENSITIVITY CONTROLS (CTK HS CONTROL) CARDIAC CONTROL - LEVEL 1 (CRD CONTROL 1) Liquid Frozen Bilirubin Control - Level 1 Liquid Frozen Bilirubin Control - Level 2 CARDIAC CONTROL - LEVEL 2 (CRD CONTROL 2) ABAXIS CHEMISTRY CONTROL LEVEL 1 ABAXIS CHEMISTRY CONTROL LEVEL 2 SERUM INDICES (SERUM INDICES) LIQUID CARDIAC CONTROL 2 LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3) PRE-ECLAMPSIA CONTROL LEVEL 3 (Pre-eclampsia CONTROL 3) LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1) LIQUID CARDIAC CONTROL 3 PRE-ECLAMPSIA CONTROL LEVEL 2 (Pre-eclampsia CONTROL 2) LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2) LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2) PRE-ECLAMPSIA CONTROL LEVEL 1 (Pre-eclampsia CONTROL 1) Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3)

    Establishment Types

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