RANDOX LABORATORIES LIMITED

FDA Device Registration & Listing · CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB · Registration 3004493545

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
3004493545
FEI Number
3004493545
Entity Name
RANDOX LABORATORIES LIMITED
City/State/Country
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Establishment Address
36 / 44 LARGY ROAD, CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey BT29 4RN, GB
Establishment Type(s)
Manufacture 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
K012319
PMA Number
N/A

All Registered Proprietary Names

RANDOX CREATININE Direct Bilirubin_2 (DBIL_2) Reagents Atellica CH Alpha-1-antitrypsin (AAT) Randox Ammonia Randox Direct HDL Cholesterol (liqu Direct HDL Cholesterol (D-HDL) Reagents Atellica CH ?2-Microglobulin Calibrator (B2M CAL) Beta-2-Microglobulin (B2M) Calibrators Beta-2-Microglobulin (B2M) Reagents 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) RANDOX CK-MB (NAC-ACTIVATED) RANDOX CK NAC-ACTIVATED Randox Microalbumin Control Level 1 and Level 2 ADVIA Chemistry Lipoprotein(a) Calibrator Atellica CH Lipoprotein(a) (Lp(a)) Atellica CH Lipoprotein(a) Calibrator (Lp(a) CAL) ADVIA Chemistry Lipoprotein(a) Reagent Blood Gas Controls RANDOX DIGOXIN Digoxin (DIG) Reagents RANDOX URIC ACID Randox Haemoglobin Control RANDOX HAEMOGLOBIN F AND A2 CONTROLS - LEVEL 1 AND 2 (Hb F & A2 CONTROL) ADVIA Chemistry Myoglobin Reagent ADVIA Chemistry Myoglobin Calibrator Randox LDL Cholesterol (Liquid) Atellica CH LDL Cholesterol Direct (DLDL) ADVIA Chemistry XPT LDL Cholesterol Direct (DLDL) Direct LDL Cholesterol (DLDL) Reagents Randox Immunoassay Controls RANDOX GLUCOSE GODIPAP PAP RANDOX GLUCOSE GOD RANDOX URIC ACID (UA) RANDOX IGE Liquid assayed chemistry control premium plus level 1,2 & 3 RANDOX URINARY PROTEIN Atellica CH Amylase_2 (AMY_2) Cardiac Linearity Verifiers Aldolase Calibrator Synthetic Cannabinoids Microtitre Plate RANDOX ALKALINE PHOSPHATASE RANDOX GLUCOSE HEXOKINASE Randox Liquid Protein Calibrator RANDOX BUTYRYL CHOLINESTERASE (CHE) Atellica CH Glucose Hexokinase_3 (GluH_3) RANDOX AMIKACIN RANDOX FRUCTOSAMINE CALIBRATOR RANDOX FRUCTOSAMINE CO RANDOX FRUCTOSAMINE CONTROL (LEVEL 3) RANDOX FRUCTOSAMINE CONTROL (LEVELS Randox Aldolase RANDOX TRANSFERRIN ADVIA Chemistry Fructosamine Calibrator ADVIA Chemistry Fructosamine Reagent Atellica CH Fructosamine (Fruc) Atellica CH Fructosamine Calibrator Liquid Immunoassay Premium Controls Cystatin C Controls RANDOX DIGITOXIN 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) RANDOX GLUTATHIONE REDUCTASE (GLUT RED) RANDOX LIPOPROTEIN A RANDOX FERRITIN HAEMOGLOBIN A1c CONTROL SET CRP Calibrator Wide Range C-Reactive Protein (wrCRP) Calibrators Atellica CH Magnesium (Mg) Liquid Protein Calibrators, neat sa Atellica CH Creatine Kinase (CK_L) Randox Maternal Controls Level 1, 2 and 3 Liquid CK-MB and Calibrator LEVEL 2 CHEMISTRY CONTROLS LEVEL 1 CHEMISTRY CONTROLS GEMCAL RANDOX TOTAL PROTEIN (UP) RANDOX URINARY PROTEIN Microalbumin (μALB) Reagents RANDOX GENTAMICIN RANDOX HEMOGLOBIN AIC RANDOX HAEMOGLOBIN AIC RANDOX HAEMOGLOBIN A Randox CRP Controls RANDOX ALT 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 RANDOX ALPHA-1-ACID-GLYCOPROTEIN (AGT) Atellica CH Alpha-1-acid Glycoprotein (AAG) Alpha-1-Acid Glycoprotein (AAG) Reagents Atellica® CH Calcium_2 (CA_2) Calcium_2, Concentrated (CA_2c) Reagents Calcium_2 (CA_2) Reagents Randox Tri Level Lipid Controls Randox Aspartate Aminotransferase RANDOX ASPARTATE AMINOTRANSFERASE (AST) Pancreatic Amylase (PAMY) Reagents Randox Pancreatic Amylase Atellica CH Pancreatic Amylase (PAmy) ADVIA Chemistry XPT Pancreatic Amylase (PAMY) RANDOX AMYLASE REAGENT RANDOX DIRECT HDL-CHOLESTEROL (HDL) RANDOX DIRECT HDL-CH Direct Bilirubin (DBIL) Special Chemistry Calibrators ADVIA Chemistry Special Chem Calibrator Acid Phosphatase (ACP) Reagents ConcizuTrace™ ELISA RANDOX DIRECT LDL-CHOLESTEROL (LDL) RANDOX MYOGLOBIN Cholesterol ADVIA Chemistry XPT Cholesterol Concentrated (CHOL_c) Atellica CH Cholesterol_2 (Chol_2) Gamma-Glutamyl Transferase (GGT) Reagents Randox Aldolase Controls Levels 2 and 3 RANDOX LIPASE (LPS) ADVIA Chemistry XPT Lipase (LIP) RANDOX LIPASE Lipase (LIP) Reagents Randox Rx Daytona Plus Magnesium (MG) Protein 1 Linearity Verifers RANDOX GAMMA-GLUTAMYLTRANSERASE (GGT) RANDOX GAMMA-GLUTA Atellica CH Gamma-Glutamyl Transferase (GGT) 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) RANDOX IGM (IMMUNO RX IMOLA Atellica CH Apolipoprotein A-1 (APO A1) Atellica CH Apolipoprotein B (APO B) RANDOX ANTI-STREPTOLYSIN-O 2 (ASO 2) Atellica CH Anti-Streptolysin-O_2 (ASO_2) RANDOX NITROGEN RANDOX UREA ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 ADVIA Chemistry Triglycerides_2 Reagent (TRIG_2) ADVIA Chemistry Triglycerides_2 concentrated Reagent (TRIG_c) Triglycerides Atellica CH Microalbumin_2 Calibrator (?ALB_2 CAL) Microalbumin_2 (µALB_2) Calibrators Protein 4 Linearity Verifiers NEFA Randox Cholesterol RANDOX CHOLESTEROL (CHOL) RX DAYTONA RANDOX HIGH SENSITIVITY C-REACTIVE RANDOX CRP LATEX SLIDE TEST E TEST Evidence MultiSTAT DOA Urine Multiplex Evidence MultiSTAT Hemoglobin A1c (HbA1c) Reagents RANDOX APOLIPOPROTEIN CALIBRATOR Apolipoprotein A-1/B Calibrators RANDOX APOUPOPROTEIN CALIBRATOR RADOX APOLIPOPROTEIN RANDOX CALCIUM RANDOX Non-Esterified Fatty Acids (NEFA) Immunoassay Speciality Control 1 Level 1, 2 and 3 Atellica CH Cystatin C_2 (CYSC_2) CAL Cystatin C Cystatin C (CYSC) Reagents Cystatin C (CYSC) Calibrators Randox Ecstasy (MDMA) Assay, calibrators and controls RANDOX THERAPEUTIC DRUG CALIBRATORS TDM Calibrators ADVIA Chemistry XPT Complement C4 (C4) Atellica CH Complement C4 (C4) RANDOX COMPLEMENT C4 Complement C4 (C4) Reagents Cholinesterase (CHE) Reagents RANDOX THEOPHYLLINE Glutathione Reductase Randox Calcium (Ca) RANDOX LITHIUM Evidence MultiSTAT DOA Urine Multiplex Randox RF Immunoturbidimetric ADVIA Chemistry XPT Rheumatoid Factor (RF) Atellica CH Rheumatoid Factor (RF) Rheumatoid Factor (RF) Reagents RANDOX CK-MB (NAC-ACTIVATED) RANDOX ALANINE AMINOTRANSFERASE (ALT) Atellica CH Alanine Aminotransferase (ALT) Atellica CH Alanine Aminotransferase P5P (ALTPLc) Atellica CH Aspartate Aminotransferase (AST) Atellica CH Albumin (Alb) Atellica CH Iron_2 (Iron_2) Atellica CH Inorganic Phosphorus (IP) Atellica CH Calcium (Ca) Atellica CH Uric Acid (UA) Atellica CH Urea Nitrogen (UN_c) Protein 3 Linearity Verifiers 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) RANDOX IGA (IMMUNO Synthetic Cannabinoids Conjugate RANDOX BILIRUBIN RANDOX MICROALBUMIN RANDOX PHENOBARBITAL RANDOX ALBUMIN RANDOX LACTATE DEHYDROGENASE ADVIA Chemistry ALP_2c Reagent Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c) Ammonia (AMM) Reagents Randox Fructosamine NORMAL SALINE (NS) RX DAYTONA CHLORIDE ISE SODIUM ISE POTASSIUM ISE Randox Urinalysis Control Homocysteine RANDOX RHEUMATOID FA RANDOX RHEUMATOID FACTOR LATEX SLIDE TEST RANDOX TOTAL-IRON BINDING CAPACITY (TIBC) RANDOX IRON (Fe) RANDOX TOTAL IRON BINDING CAPACITY 2 (TIBC_2) D3-Hydroxybutyrate RANDOX TOTAL IRON BINDING CAPACITY 2 RANDOX TOTAL IRON BINDING CAPACITY RANDOX IRON Lipid Multiconstituent Calibrator (model 05P5601) Randox Apolipoprotein B Randox Direct LDL and HDL Cholesterol Calibrator HDL/LDL Cholesterol Calibrators Immunoassay Speciality Controls RANDOX IGG (IMMUNOTURBIOIMETRIC) RANDOX IGG (IMMUNOTURBIDIMETRIC) ADVIA Ferritin Ferritin (FRT) Reagents Randox multisera, human, assayed an Atellica CH Creatinine_2 (Crea_2) RANDOX MICROALBUMIN (mALB) Atellica CH Microalbumin_2 (?ALB_2) L-LACTATE (LAC) Atellica CH Lactate_2 (Lac_2) Cholesterol, Concentrated (CHOL_c) Reagents Cholesterol_2 (CHOL_2) Reagents Liquid CO2-2 (LCO2-2) Immunoassay Premium Plus Controls RANDOX INORGANIC PHOSPHOROUS RANDOX INORGANIC PHOSPHORUS RANDOX HUMAN ASSAYED DRUG CONTROL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2007-08-01
JFM Enzymatic Method, Bilirubin Clinical Chemistry Class 2 862.1110 2012-12-21
DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control Immunology Class 2 866.5130 2012-12-21
JIF Enzymatic Method, Ammonia Clinical Chemistry Class 1 862.1065 2008-02-05
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2008-02-05
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
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
CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2006-10-18
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-09-03
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
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-02-18
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2007-08-01
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2007-08-01
GGM Control, Hemoglobin Hematology Class 2 864.8625 2017-12-13
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2012-12-24
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2012-12-24
MRR System, Test, Low Density, Lipoprotein Clinical Chemistry Class 1 862.1475 2007-08-01
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-02-05
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2007-08-01
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2018-07-26
DGC Ige, Antigen, Antiserum, Control Immunology Class 2 866.5510 2007-08-01
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2014-12-09
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2007-08-01
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2019-08-28
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-11-02
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2014-09-19
JRA Microtitrator, For Clinical Use Clinical Chemistry Class 1 862.2680 2012-12-12
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2007-08-01
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2007-08-01
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2008-02-06
DIH Colorimetry, Cholinesterase Clinical Toxicology Class 1 862.3240 2018-07-26
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2012-12-21
KLQ Radioimmunoassay, Amikacin Clinical Toxicology Class 2 862.3035 2007-09-13
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2003-08-11
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2003-08-11
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2003-08-11
CJC Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase Clinical Chemistry Class 1 862.1040 2011-08-03
DDG Transferrin, Antigen, Antiserum, Control Immunology Class 2 866.5880 2007-08-01
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2014-02-11
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2014-02-11
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-12-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-06-26
LFM Enzyme Immunoassay, Digitoxin Clinical Toxicology Class 2 862.3300 2007-08-01
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2018-07-11
KQF Assay, Glutathione Reductase Hematology Class 2 864.7375 2018-07-26
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2007-08-01
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2007-08-01
DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control Immunology Class 2 866.5600 2007-08-01
DBF Ferritin, Antigen, Antiserum, Control Immunology Class 2 866.5340 2007-08-01
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-07-30
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2008-02-05
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2017-09-11
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2008-02-06
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2017-09-11
CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2017-09-11
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2012-09-25
CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2013-11-25
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2013-11-25
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2014-03-07
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2014-03-07
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2014-03-07
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 1997-04-08
LCD Enzyme Immunoassay, Gentamicin Clinical Toxicology Class 2 862.3450 2007-08-01
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2007-08-01
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-02-05
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt Clinical Chemistry Class 1 862.1030 2007-08-01
PQD Blood Specimen Collection Convenience Kit (Excludes Hiv) Clinical Chemistry Class 2 862.1675 2023-07-31
LKL Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control Immunology Class 1 866.5420 2013-01-03
CJY Azo Dye, Calcium Clinical Chemistry Class 2 862.1145 2012-12-21
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-02-06
CIS Hydrazone Colorimetry, Ast/Sgot Clinical Chemistry Class 2 862.1100 2017-12-13
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 1997-06-11
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 1997-03-04
JFM Enzymatic Method, Bilirubin Clinical Chemistry Class 2 862.1110 2016-02-25
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2006-09-08
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2006-09-08
CKB Acid Phosphatase, Naphthyl Phosphate Clinical Chemistry Class 2 862.1020 2006-09-08
SES Non-Factor Replacement Product Test System Hematology Class 2 864.7298 2025-05-29
MRR System, Test, Low Density, Lipoprotein Clinical Chemistry Class 1 862.1475 2018-07-26
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2007-08-01
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2015-10-20
JQA Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes Clinical Chemistry Class 1 862.1360 2013-01-03
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-07-22
CHI Lipase-Esterase, Enzymatic, Photometric, Lipase Clinical Chemistry Class 1 862.1465 2002-05-02
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2017-05-02
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-03-10
JPZ Colorimetric Method, Gamma-Glutamyl Transpeptidase Clinical Chemistry Class 1 862.1360 1997-03-20
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2018-07-27
DFT Igm, Antigen, Antiserum, Control Immunology Class 2 866.5550 2007-08-01
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2004-03-16
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2004-03-16
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2004-03-16
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2004-03-16
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2004-03-16
JHN Turbidimetric Method, Lipoproteins Clinical Chemistry Class 1 862.1475 1997-03-06
GTQ Antistreptolysin - Titer/Streptolysin O Reagent Microbiology Class 1 866.3720 1997-09-26
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2007-08-01
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2014-03-07
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2014-03-07
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2014-03-07
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2014-01-15
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2015-10-20
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2012-12-24
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2016-03-10
JLH Titrimetric, Fatty Acids Clinical Chemistry Class 1 862.1290 2012-06-21
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 1997-03-04
JJF Analyzer, Chemistry, Micro, For Clinical Use Clinical Chemistry Class 1 862.2170 2004-02-09
DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 1997-03-04
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
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2012-12-21
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2007-08-01
CIC Cresolphthalein Complexone, Calcium Clinical Chemistry Class 2 862.1145 2007-08-01
JLG Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids Clinical Chemistry Class 1 862.1290 2011-08-04
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-07-02
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2011-11-29
NDY Test, Cystatin C Clinical Chemistry Class 2 862.1225 2011-11-29
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2011-07-11
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2011-07-11
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2011-07-11
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2007-09-13
DBI Complement C4, Antigen, Antiserum, Control Immunology Class 2 866.5240 2007-08-01
DIH Colorimetry, Cholinesterase Clinical Toxicology Class 1 862.3240 2012-12-21
KLS Enzyme Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2006-09-08
JLO Enzymatic (Glutathione Reductase), Glutathione Clinical Chemistry Class 1 862.1365 2012-08-29
CJY Azo Dye, Calcium Clinical Chemistry Class 2 862.1145 2019-03-11
JII Atomic Absorption, Lithium Clinical Toxicology Class 2 862.3560 2006-09-08
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
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2008-02-06
JLB Atp And Creatine Kinase (Enzymatic), Creatine Clinical Chemistry Class 1 862.1210 1997-03-04
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt Clinical Chemistry Class 1 862.1030 1997-03-20
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2006-09-08
CJK Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2006-09-08
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2006-09-08
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2006-09-08
KHM Nephelometric, Amylase Clinical Chemistry Class 2 862.1070 2006-09-08
CFO Titrimetric, Magnesium Clinical Chemistry Class 1 862.1495 2006-09-08
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2006-09-08
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2006-09-08
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2006-09-08
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2006-09-08
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2006-09-08
CIC Cresolphthalein Complexone, Calcium Clinical Chemistry Class 2 862.1145 2006-09-08
CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2006-09-08
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2006-09-08
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2006-09-08
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2006-09-08
JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry Class 1 862.1410 2006-09-08
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2016-03-10
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-02-16
CZP Iga, Antigen, Antiserum, Control Immunology Class 2 866.5510 2007-08-01
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2012-12-12
GIG Hemoglobinometer Hematology Class 2 864.7500 2007-09-13
DDZ Albumin, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5040 2007-08-01
DLZ Enzyme Immunoassay, Phenobarbital Clinical Toxicology Class 2 862.3660 2007-08-01
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2007-08-01
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase Clinical Chemistry Class 2 862.1440 2007-08-01
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2015-07-01
CJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2015-07-01
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2012-12-21
JIF Enzymatic Method, Ammonia Clinical Chemistry Class 1 862.1065 2012-12-21
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2011-11-01
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-11-01
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2011-11-01
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2007-08-01
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2007-08-01
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2007-08-01
JJF Analyzer, Chemistry, Micro, For Clinical Use Clinical Chemistry Class 1 862.2170 2007-08-01
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2007-08-01
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2007-08-01
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-11-01
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2013-04-10
LPS Urinary Homocystine (Nonquantitative) Test System Clinical Chemistry Class 2 862.1377 2013-04-10
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2007-08-01
JMO Ferrozine (Colorimetric) Iron Binding Capacity Clinical Chemistry Class 1 862.1415 2018-07-26
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2012-06-21
JMO Ferrozine (Colorimetric) Iron Binding Capacity Clinical Chemistry Class 1 862.1415 2007-08-01
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2014-02-06
JHN Turbidimetric Method, Lipoproteins Clinical Chemistry Class 1 862.1475 2008-02-05
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2012-09-03
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2012-12-05
DEW Igg, Antigen, Antiserum, Control Immunology Class 2 866.5510 2007-08-01
DBF Ferritin, Antigen, Antiserum, Control Immunology Class 2 866.5340 2011-08-30
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-08-30
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2007-08-01
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2017-09-11
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2017-09-11
DDZ Albumin, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5040 2000-10-18
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2011-08-03
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2012-12-21
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2016-02-25
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2014-05-23
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2007-08-01
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2004-10-19

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
3014607865 RANDOX LABORATORIES LIMITED ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, GB
3009473156 Randox Teoranta Dungloe Donegal, IE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242685 Siemens Healthcare Diagnostics, Inc. Atellica® CH Creatinine_3 (Crea3) 2024-12-04
K161494 Siemens Healthcare Diagnostics, Inc. Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) 2016-11-15
K760034 Gamma Biologicals, Inc. TEST, STREP, LATEX SLIDE 1976-08-11
K882259 Diagnostic Chemicals, Ltd. (Usa) DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 1988-07-21
K060322 Cliniqa Corporation CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED 2006-03-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2009 Roche Diagnostics Corp. 2
Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma.
Z-0002-2018 The Binding Site Group, Ltd. 2
Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
Z-0015-2008 Thermo Fisher Scientific 1
Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
Z-0010-2009 Roche Diagnostics Corp. 1
Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma.
Z-0024-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004493545. Last updated year: 2026. Please use registration number 3004493545 when referencing this establishment in official correspondence.
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