BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    PTH CONTROL LEVEL 1 (PTH CONTROL 1)

    Reg #: 3004493545 · FEI: 3004493545 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    37
    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
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    PTH CONTROL LEVEL 1 (PTH CONTROL 1) GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL) G-6-PDH NORMAL CONTROL (G-6-PDH CONTROL N) PARATHYROID HORMONE CONTROL - LEVEL 2 (PTH CONTROL 2) PARATHYROID HORMONE CONTROL - LEVEL 1 (PTH CONTROL 1) sLDL CONTROL LEVEL 1 (sLDL CONTROL 1) sLDL CONTROL LEVEL 2 (sLDL CONTROL 2) GLYCEROL CONTROL (GLY CONTROL) G-6-PDH DEFICIENT CONTROL (G-6-PDH CONTROL D) sLDL CONTROL LEVEL 3 (sLDL CONTROL 3) PARATHYROID HORMONE CONTROL - LEVEL 3 (PTH CONTROL 3) ADIPONECTIN CONTROL - LEVEL 2 (ADPN CONTROL 2) Liquid Glycated Haemoglobin (HbA1c) Control - Level 2 (LIQ HbA1c CONTROL LEVEL 2) ADIPONECTIN CONTROL - LEVEL 3 (ADPN CONTROL 3) Liquid Glycated Haemoglobin (HbA1c) Control set (LIQ HbA1c CONTROL) HIGH SENSITIVITY C-REACTIVE PROTEIN LINEARITY VERIFIERS (For Roche Series) (HSCPLV) Liquid Glycated Haemoglobin (HbA1c) Control - Level 1 (LIQ HbA1c CONTROL LEVEL 1) RHEUMATOID FACTOR LINEARITY VERIFIERS (For Roche Systems) (RFLV) SARS CoV-2 Controls (SARS-CoV-2) C-REACTIVE PROTEIN LINEARITY VERIFIERS (For Roche Series) (CPLV) RANSEL CONTROL CARDIAC ULTRA LOW CONTROL (CRD CONTROL Ultra Low) SOLUBLE TRANSFERRIN RECEPTORS CONTROLS (STFR CONTROLS) TOTAL ANTIOXIDANT STATUS (TAS CONTROL) CYSTATIN C CONTROL - LEVEL 2 (CYSC CONTROL 2) RANSOD CONTROL CYSTATIN C CONTROL - LEVEL 3 (CYSC CONTROL 3) AMH CONTROL LEVEL 2 (AMH CONTROL 2) AMH CONTROL LEVEL 3 (AMH CONTROL 3) ACTIVE VITAMIN B12 CONTROL LEVEL 2 (Active Vitamin B12 CONTROL 2) AMH CONTROL LEVEL 1 (AMH CONTROL 1) ACTIVE VITAMIN B12 CONTROL LEVEL 1 (Active Vitamin B12 CONTROL 1) PTH CONTROL LEVEL 2 (PTH CONTROL 2) PTH CONTROL LEVEL 3 (PTH CONTROL 3) AMH CONTROL LEVEL 4 (AMH CONTROL 4) BNP CONTROLS FOR BECKMAN (BNP CONTROL) BNP CONTROLS FOR ABBOTT (BNP CONTROL)

    Establishment Types

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