RANDOX LABORATORIES LIMITED

FDA Device Registration & Listing · ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, GB · Registration 3014607865

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014607865
FEI Number
3014607865
Entity Name
RANDOX LABORATORIES LIMITED
City/State/Country
ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, GB
Establishment Address
30 RANDALSTOWN ROAD, ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey BT41 4FL, GB
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device,Repack or Relabel Medical Device
Owner / Operator
RANDOX LABORATORIES, LTD. (Owner Number: 8020890)
Owner / Operator Contact Address
55 DIAMOND RD., --, CRUMLIN, CO.ANTRIM, GB-NOTA BT29 4QY, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1) LIQUID BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1) COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2) LIQUID FROZEN LIPID CONTROL - LEVEL 1 (LIQ LPD CONTROL 1) LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM – LEVEL 2 (LIQ CHEM ASY PREMIUM 2) LIQUID CSF CONTROL - LEVEL 2 (CSF CONTROL 2) CHEMISTRY PREMIUM - LEVEL 3 (CHEM PREMIUM 3) CHEMISTRY PREMIUM - LEVEL 2 (CHEM PREMIUM 2) LIQUID CSF CONTROL - LEVEL 1 (CSF CONTROL 1) LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM – LEVEL 3 (LIQ CHEM ASY PREMIUM 3) COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3) ASSAYED BOVINE MULTI SERA - LEVEL 2 (BOV ASY CONTROL 2) BILIRUBIN ELEVATED SERUM (BIL CONTROL H) APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1) ESOTERIC LINEARITY VERIFIERS (For Roche Systems) (ESOTERIC LIN VER ROCHE) LIQUID FROZEN LIPID CONTROL - LEVEL 2 (LIQ LPD CONTROL 2) LIQUID FROZEN LIPID CONTROL - LEVEL 3 (LIQ LPD CONTROL 3) LIPID LINEARITY VERIFIERS (For Roche Systems) (LLV-R) APOLIPOPROTEIN CONTROL - LEVEL 2 (APO CONTROL 2) ASSAYED BOVINE MULTI SERA - LEVEL 1 (BOV ASY CONTROL 1) SPECIFIC PROTEIN CONTROL - LEVEL 2 (SP CONTROL 2) COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) APOLIPOPROTEIN CONTROL - LEVEL 3 (APO CONTROL 3) SPECIFIC PROTEIN CONTROL - LEVEL 1 (SP CONTROL 1) LIQUID BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2) ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3) SPECIFIC PROTEIN CONTROL - LEVEL 3 (SP CONTROL 3) APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R) LIPID LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Lipid LinVer - BC) BILIRUBIN LINEARITY VERIFIER (For Roche Systems) (BILIRUBIN LIN VER ROCHE) RANDOX SERUM DILUENT (DIL SM) LIAISON Endocrinology Calibration Verifiers CO2/ELECTROLYTE LINEARITY VERIFIERS (For Roche Systems) (CO2 LIN VER) APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Apo LinVer - BC) CYTOKINE CONTROL ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE) CLINICAL CHEMISTRY LINEARITY VERIFIERS (For Roche Systems) (LIQ CLIN CHEM LIN VER) CYTOKINE HIGH SENSITIVITY CONTROLS (CTK HS CONTROL) Liquid Frozen Bilirubin Control - Level 1 Liquid Frozen Bilirubin Control - Level 2 CARDIAC CONTROL - LEVEL 3 (CRD CONTROL 3) CARDIAC CONTROL - LEVEL 1 (CRD CONTROL 1) CARDIAC CONTROL - LEVEL 2 (CRD CONTROL 2) PRE-ECLAMPSIA CONTROL LEVEL 2 (Pre-eclampsia CONTROL 2) PRE-ECLAMPSIA CONTROL LEVEL 3 (Pre-eclampsia CONTROL 3) SERUM INDICES (SERUM INDICES) ABAXIS CHEMISTRY CONTROL LEVEL 1 LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2) LIQUID CARDIAC CONTROL 3 LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3) Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) PRE-ECLAMPSIA CONTROL LEVEL 1 (Pre-eclampsia CONTROL 1) Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3) LIQUID CARDIAC CONTROL 2 ABAXIS CHEMISTRY CONTROL LEVEL 2 LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2) Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) LIQUID CARDIAC CONTROL 1 LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3) LIQUID IMMUNOASSAY CONTROL - LEVEL 1 (IA CONTROL 1) C-Reactive Protein_2 (CRP_2) Reagents Atellica CH C-Reactive Protein_2 Calibrators (CRP_2 CAL) Atellica CH C-Reactive Protein_2 (CRP_2) C-Reactive Protein_2 (CRP_2) Calibrators RANDOX MICROALBUMIN (mALB) Atellica CH Microalbumin_2 (?ALB_2) Evidence MultiSTAT DOA Urine Multiplex ConcizuTrace™ ELISA ASPARTATE AMINOTRANSFERASE (AST) RX daytona plus (with ISE) H SOLUTION (H SOLN) ETCHING (ETCH) I.S.E. CLEANER (ISE CLN) REFERENCE SOLUTION (REF SOLN) I.S.E. DILUENT (ISE DIL) RX daytona plus (without ISE) SALINE DILUENT (NS) ACID WASH SOLUTION (AWS) L SOLUTION (L SOLN) Apolipoprotein Control Levels 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 General Chemistry Control Level 1, 2 and 3 RANDOX LIQUID CHEMISTRY PREMIUM PLUS CONTROLS RANDOX BOVINE PRECISION CONTROLS BOVINE PRECISION MULTI SERA - LEVEL 1 (BOV PREC CONTROL 1) RANDOX PRECISION CHEMISTRY PREMIUM PLUS CONTROLS LIQUID CHEMISTRY PREMIUM - LEVEL 2 (LIQ CHEM PREMIUM 2) HUMAN PRECISION CONTROL - LEVEL 3 (HUM PREC CONTROL 3) BOVINE PRECISION MULTI SERA - LEVEL 2 (BOV PREC CONTROL 2) RANDOX LIQUID CHEMISTRY PREMIUM CONTROLS BOVINE PRECISION MULTI SERA - LEVEL 3 (BOV PREC CONTROL 3) LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 1 (LIQ CHEM PREMIUM PLUS 1) LIQUID CHEMISTRY PREMIUM - LEVEL 3 (LIQ CHEM PREMIUM 3) LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 3 (LIQ CHEM PREMIUM PLUS 3) LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 2 (LIQ CHEM PREMIUM PLUS 2) RANDOX HUMAN PRECISION CONTROLS SEROLOGY III POSITIVE CONTROL (SEROLOGY III CONTROL +) RANDOX BOVINE PRECISION MULTI SERA HUMAN PRECISION CONTROL - LEVEL 2 (HUM PREC CONTROL 2) SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +) SEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL +) SEROLOGY ToRCH IgG POSITIVE CONTROL (ToRCH IgG CONTROL +) SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +) SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -) SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -) SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +) Randox Liquid Chemistry Premium Plus levels 1,2 and 3 SERUM INDICES (SERUM INDICES) XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA CONTROL +) XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA CONTROL -) PSA Custom Control Levels 1, 2 and 3, IAC129, IAC130, IAC131 Custom Cardiac Controls Levels 1, 2 and 3, CQ039, CQ040, CQ041 Atellica CH ?2-Microglobulin Calibrator (B2M CAL) Beta-2-Microglobulin (B2M) Calibrators Beta-2-Microglobulin (B2M) Reagents ADVIA Chemistry Lipoprotein(a) Calibrator Atellica CH Lipoprotein(a) (Lp(a)) Atellica CH Lipoprotein(a) Calibrator (Lp(a) CAL) ADVIA Chemistry Lipoprotein(a) Reagent Evidence MultiSTAT DOA Urine Multiplex Randox CRP Immunoturbidimetric kit Randox Cardiac Controls RANDOX ALPHA-1-ACID-GLYCOPROTEIN (AGT) Atellica CH Alpha-1-acid Glycoprotein (AAG) Alpha-1-Acid Glycoprotein (AAG) Reagents PlaySafe™ RANDOX PREALBUMIN THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems) (TDM LIN VER ROCHE) Lipid Multiconstituent Calibrator (model 05P5601) Evidence MultiSTAT DOA Urine Multiplex Evidence MultiSTAT sLDL CONTROL LEVEL 1 (sLDL CONTROL 1) sLDL CONTROL LEVEL 2 (sLDL CONTROL 2) ADIPONECTIN CONTROL - LEVEL 2 (ADPN CONTROL 2) GLYCEROL CONTROL (GLY CONTROL) sLDL CONTROL LEVEL 3 (sLDL CONTROL 3) Liquid Glycated Haemoglobin (HbA1c) Control - Level 1 (LIQ HbA1c CONTROL LEVEL 1) G-6-PDH DEFICIENT CONTROL (G-6-PDH CONTROL D) ADIPONECTIN CONTROL - LEVEL 3 (ADPN CONTROL 3) PARATHYROID HORMONE CONTROL - LEVEL 3 (PTH CONTROL 3) PARATHYROID HORMONE CONTROL - LEVEL 1 (PTH CONTROL 1) RANSEL CONTROL C-REACTIVE PROTEIN LINEARITY VERIFIERS (For Roche Series) (CPLV) G-6-PDH NORMAL CONTROL (G-6-PDH CONTROL N) GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL) PARATHYROID HORMONE CONTROL - LEVEL 2 (PTH CONTROL 2) RHEUMATOID FACTOR LINEARITY VERIFIERS (For Roche Systems) (RFLV) Liquid Glycated Haemoglobin (HbA1c) Control set (LIQ HbA1c CONTROL) Liquid Glycated Haemoglobin (HbA1c) Control - Level 2 (LIQ HbA1c CONTROL LEVEL 2) HIGH SENSITIVITY C-REACTIVE PROTEIN LINEARITY VERIFIERS (For Roche Series) (HSCPLV) SARS CoV-2 Controls (SARS-CoV-2) TOTAL ANTIOXIDANT STATUS (TAS CONTROL) RANSOD CONTROL CARDIAC ULTRA LOW CONTROL (CRD CONTROL Ultra Low) SOLUBLE TRANSFERRIN RECEPTORS CONTROLS (STFR CONTROLS) CYSTATIN C CONTROL - LEVEL 3 (CYSC CONTROL 3) CYSTATIN C CONTROL - LEVEL 2 (CYSC CONTROL 2) AMH CONTROL LEVEL 4 (AMH CONTROL 4) AMH CONTROL LEVEL 3 (AMH CONTROL 3) BNP CONTROLS FOR ABBOTT (BNP CONTROL) ACTIVE VITAMIN B12 CONTROL LEVEL 2 (Active Vitamin B12 CONTROL 2) BNP CONTROLS FOR BECKMAN (BNP CONTROL) AMH CONTROL LEVEL 1 (AMH CONTROL 1) PTH CONTROL LEVEL 2 (PTH CONTROL 2) AMH CONTROL LEVEL 2 (AMH CONTROL 2) ACTIVE VITAMIN B12 CONTROL LEVEL 1 (Active Vitamin B12 CONTROL 1) PTH CONTROL LEVEL 3 (PTH CONTROL 3) PTH CONTROL LEVEL 1 (PTH CONTROL 1) 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 ADVIA Chemistry Fructosamine Calibrator ADVIA Chemistry Fructosamine Reagent Atellica CH Fructosamine (Fruc) Atellica CH Fructosamine Calibrator Atellica CH Liquid Specific Protein Calibrators (LSP CAL) Consolidated Chemistry Calibrator (ARCHITECT; LN 04V1501) Consolidated Chemistry Calibrator (ALINITY; LN 04V6201) Lipid Multiconstituent Calibrator Kit Lipid Multiconstituent Calibrator Atellica CH Apolipoprotein A-1 & B Calibrator (APO A1 & B CAL) Atellica CH Special Chemistry Calibrator (SPCL CHEM CAL) APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) BETA 2 MICROGLOBULIN CALIBRATOR (B2M CAL) GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL) ANTI-STREPTOLYSIN O STANDARD (ASO STD) COAGULATION CALIBRATOR (COAG CAL) ADIPONECTIN CALIBRATOR (ADPN CAL) sLDL CALIBRATOR (sLDL CAL) MICROALBUMIN CALIBRATOR SERIES (mALB CAL) IMMUNOGLOBULIN LIQUID PROTEIN CALIBRATOR (IG CAL) HbA1c II CALIBRATOR SET (HbA1c II CAL) RANSEL CALIBRATOR (RANSEL CAL) SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES (STFR CAL) CYSTATIN C CALIBRATOR (CYSC CAL)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2018-06-18
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2012-12-21
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2012-12-21
DDZ Albumin, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5040 2000-10-18
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2026-01-27
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2026-01-27
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2026-01-27
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2026-01-27
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2026-01-27
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2026-01-27
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2026-01-27
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2026-01-27
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2026-01-27
SES Non-Factor Replacement Product Test System Hematology Class 2 864.7298 2025-05-29
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2014-01-27
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2014-01-27
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2014-01-27
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2014-01-27
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2014-01-27
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2011-08-03
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2012-12-21
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2012-12-21
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2013-01-07
DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control Immunology Class 2 866.5600 2013-01-07
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2024-09-13
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2024-09-13
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2024-09-13
DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2008-02-05
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-02-05
LKL Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control Immunology Class 1 866.5420 2013-01-03
OIE Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2024-09-30
JZJ Prealbumin, Antigen, Antiserum, Control Immunology Class 1 866.5060 2000-09-22
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2019-07-31
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2014-02-06
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2024-09-11
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2024-09-11
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2024-09-11
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2024-09-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2024-09-11
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-02-16
PQD Blood Specimen Collection Convenience Kit (Excludes Hiv) Clinical Chemistry Class 2 862.1675 2023-07-31
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2014-02-11
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2014-02-11
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2018-07-11
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2018-07-27

Official Correspondent

Karena Shaw

US Agent Details

John Naizer Business: RANDOX LABORATORIES-US, LTD Email: John.Naizer@randox.com Phone: (304) 7282890

Related Public Records

Same Entity

RANDOX LABORATORIES, LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2086993 RANDOX LABORATORIES-US, LTD Kearneysville, WV, US
3009473156 Randox Teoranta Dungloe Donegal, IE
3004493545 RANDOX LABORATORIES LIMITED CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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K982637 Diagnostic Products Corp. IMMULITE PSA CONTROL MODULE, MODEL LPSCM 1998-08-12
K012468 Dade Behring, Inc. MODIFICATION TO N/T PROTEIN CONTROL SL 2001-09-04
K083412 Mitsubishi Kagaku Iatron PATHFAST HSCRP 2009-03-09
K041905 Instrumentation Laboratory CO HEMOSIL CALIBRATION PLASMA 2004-09-28

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014607865. Last updated year: 2026. Please use registration number 3014607865 when referencing this establishment in official correspondence.
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