FDA Registration
Active
🇬🇧 United Kingdom
RANDOX LABORATORIES LIMITED
Reg #: 3004493545
·
FEI: 3004493545
·
Expires 2026
Products
124
Proprietary Names
505
Establishment Types
4
Classifications
124
Registration Details
- Registration Name
- RANDOX LABORATORIES LIMITED
- Registration Number
- 3004493545
- FEI Number
- 3004493545
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 36 / 44 LARGY ROAD
- City
- CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K973993
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
- John Naizer
- Address
- 515 Industrial Boulevard
- City
- Kearneysville
- State
- WV
- ZIP
- 25430
- Country
- US
- [email protected]
- Phone
- 304 7282890
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2007-08-01 |
| Enzymatic Method, Bilirubin | JFM | Class 2 | Clinical Chemistry | No | 2012-12-21 |
| Alpha-1-Antitrypsin, Antigen, Antiserum, Control | DEM | Class 2 | Immunology | No | 2012-12-21 |
| Enzymatic Method, Ammonia | JIF | Class 1 | Clinical Chemistry | No | 2008-02-05 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2008-02-05 |
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2012-12-21 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2012-12-21 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2014-01-27 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2014-01-27 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2014-01-27 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2014-01-27 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2014-01-27 |
| Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | CGS | Class 2 | Clinical Chemistry | No | 2006-10-18 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2012-09-03 |
| Lipoprotein, Low-Density, Antigen, Antiserum, Control | DFC | Class 2 | Immunology | No | 2013-01-07 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2013-02-18 |
| Enzyme Immunoassay, Digoxin | KXT | Class 2 | Clinical Toxicology | No | 2007-08-01 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2007-08-01 |
| Control, Hemoglobin | GGM | Class 2 | Hematology | No | 2017-12-13 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2012-12-24 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2007-08-01 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2007-08-01 |
| Ige, Antigen, Antiserum, Control | DGC | Class 2 | Immunology | No | 2007-08-01 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2007-08-01 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2019-08-28 |
| Microtitrator, For Clinical Use | JRA | Class 1 | Clinical Chemistry | No | 2012-12-12 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2007-08-01 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2007-08-01 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2008-02-06 |
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2018-07-26 |
| Radioimmunoassay, Amikacin | KLQ | Class 2 | Clinical Toxicology | No | 2007-09-13 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2003-08-11 |
| Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase | CJC | Class 1 | Clinical Chemistry | No | 2011-08-03 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2007-08-01 |
| Enzyme Immunoassay, Digitoxin | LFM | Class 2 | Clinical Toxicology | No | 2007-08-01 |
| Assay, Glutathione Reductase | KQF | Class 2 | Hematology | No | 2018-07-26 |
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | Class 1 | Clinical Chemistry | No | 2007-08-01 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2007-08-01 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2007-08-01 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2017-09-11 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2007-08-01 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2007-08-01 |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2023-07-31 |
| Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | LKL | Class 1 | Immunology | No | 2013-01-03 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2012-12-21 |
| Hydrazone Colorimetry, Ast/Sgot | CIS | Class 2 | Clinical Chemistry | No | 2017-12-13 |
| Acid Phosphatase, Naphthyl Phosphate | CKB | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Non-Factor Replacement Product Test System | SES | Class 2 | Hematology | No | 2025-05-29 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2015-10-20 |
| Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes | JQA | Class 1 | Clinical Chemistry | No | 2013-01-03 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 2002-05-02 |
| Colorimetric Method, Gamma-Glutamyl Transpeptidase | JPZ | Class 1 | Clinical Chemistry | No | 1997-03-20 |
| Igm, Antigen, Antiserum, Control | DFT | Class 2 | Immunology | No | 2007-08-01 |
| Turbidimetric Method, Lipoproteins | JHN | Class 1 | Clinical Chemistry | No | 1997-03-06 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | Class 1 | Microbiology | No | 1997-09-26 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2007-08-01 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2014-01-15 |
| Titrimetric, Fatty Acids | JLH | Class 1 | Clinical Chemistry | No | 2012-06-21 |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2004-02-09 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 1997-03-04 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-09-11 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2024-09-11 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2024-09-11 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2024-09-11 |
| Cresolphthalein Complexone, Calcium | CIC | Class 2 | Clinical Chemistry | No | 2007-08-01 |
| Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids | JLG | Class 1 | Clinical Chemistry | No | 2011-08-04 |
| Test, Cystatin C | NDY | Class 2 | Clinical Chemistry | No | 2011-11-29 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2011-07-11 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2011-07-11 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2011-07-11 |
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2007-09-13 |
| Complement C4, Antigen, Antiserum, Control | DBI | Class 2 | Immunology | No | 2007-08-01 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2006-09-08 |
| Enzymatic (Glutathione Reductase), Glutathione | JLO | Class 1 | Clinical Chemistry | No | 2012-08-29 |
| Atomic Absorption, Lithium | JII | Class 2 | Clinical Toxicology | No | 2006-09-08 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2026-01-27 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2026-01-27 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2026-01-27 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2026-01-27 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2008-02-06 |
| Atp And Creatine Kinase (Enzymatic), Creatine | JLB | Class 1 | Clinical Chemistry | No | 1997-03-04 |
| Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes | CJK | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Nephelometric, Amylase | KHM | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Titrimetric, Magnesium | CFO | Class 1 | Clinical Chemistry | No | 2006-09-08 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2006-09-08 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2006-09-08 |
| Iga, Antigen, Antiserum, Control | CZP | Class 2 | Immunology | No | 2007-08-01 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2012-12-12 |
| Hemoglobinometer | GIG | Class 2 | Hematology | No | 2007-09-13 |
| Albumin, Fitc, Antigen, Antiserum, Control | DDZ | Class 2 | Immunology | No | 2007-08-01 |
| Enzyme Immunoassay, Phenobarbital | DLZ | Class 2 | Clinical Toxicology | No | 2007-08-01 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2007-08-01 |
| Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes | CJO | Class 2 | Clinical Chemistry | No | 2015-07-01 |
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2011-11-01 |
| Urinary Homocystine (Nonquantitative) Test System | LPS | Class 2 | Clinical Chemistry | No | 2013-04-10 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2018-07-26 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2012-06-21 |
| Igg, Antigen, Antiserum, Control | DEW | Class 2 | Immunology | No | 2007-08-01 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2011-08-03 |
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2016-02-25 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2004-10-19 |
| Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | NQD | Class 2 | Immunology | No | 2012-12-21 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 1998-03-27 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2012-12-21 |
| Immunochemical, Transferrin | JNM | Class 2 | Immunology | No | 2012-12-21 |
| Apolipoproteins | MSJ | Class 1 | Clinical Chemistry | No | 2012-12-21 |
| Method, Nephelometric, Immunoglobulins (G, A, M) | CFN | Class 2 | Immunology | No | 2012-12-21 |
| Enzyme Controls (Assayed And Unassayed) | JJT | Class 1 | Clinical Chemistry | No | 2017-12-13 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2007-08-01 |
| Tetraphenyl Borate, Colorimetry, Potassium | CEJ | Class 2 | Clinical Chemistry | No | 2007-08-01 |
| Haptoglobin, Antigen, Antiserum, Control | DAD | Class 2 | Immunology | No | 2011-08-03 |
| Saccharogenic, Amylase | CIJ | Class 2 | Clinical Chemistry | No | 2007-08-01 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2013-05-10 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | Class 1 | Immunology | No | 2007-08-01 |
| Complement C3, Antigen, Antiserum, Control | CZW | Class 2 | Immunology | No | 2007-08-01 |
| Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | JMK | Class 1 | Clinical Chemistry | No | 2022-02-25 |
| Enzyme Immunoassay, Diphenylhydantoin | DIP | Class 2 | Clinical Toxicology | No | 2004-10-22 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2011-07-28 |
| Enzyme Immunoassay, Carbamazepine | KLT | Class 2 | Clinical Toxicology | No | 2007-08-01 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2011-08-03 |
| Uranyl Acetate/Zinc Acetate, Sodium | CEI | Class 2 | Clinical Chemistry | No | 2007-08-01 |
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)
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
Randox RF Immunoturbidimetric
ADVIA Chemistry XPT Rheumatoid Factor (RF)
Atellica CH Rheumatoid Factor (RF)
Rheumatoid Factor (RF) Reagents
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)
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
Atellica CH High Sensitivity C-Reactive Protein (hsCRP)
Atellica CH High Sensitivity C-Reactive Protein Calibrator (hsCRP CAL)
RANDOX TOTAL PROTEIN 2 (TP 2)
Atellica CH Total Protein II
DIRECT HDL-CHOLESTEROL (LYO)
RANDOX DIRECT HDL CH
RANDOX DIRECT HDL-C
RANDOX AST
Randox Opiates Assay
Atellica CH Cystatin C_2 (CYSC_2)
Atellica CH Immunoglobulin G_2 (IgG_2)
Atellica CH Transferrin (Trf)
Atellica CH Immunoglobulin A_2 (IgA_2)
Atellica CH Immunoglobulin M_2 (IgM_2)
Atellica CH TDM Calibrators (TDM CAL)
Randox Adiponectin Control
Randox G6PDH Control
Randox Parathyroid Hormone control
Randox Urine Controls
RANDOX VALPROIC ACID
Protein 2 Linearity Verifiers
Direct LDL Cholesterol (LDL)
RANDOX INORGANIC PHOSPHOROUS (PHOS)
Total Bilirubin_2 (TBIL_2) Reagents
RANDOX POTASSIUM
RANDOX HAPTOGLOBIN (HP)
Randox Haptoglobin
Haptoglobin (HAPT) Reagents
Randox Homocysteine
High Sensitivity/Full Range CRP
Wide Range C-Reactive Protein (wrCRP) Reagents
THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems) (TDM LIN VER ROCHE)
RANDOX AMYLASE (ETHYLIDENE PNPG7)
RANDOX AMYLASE (ETHYLIPENE PNPG7)
Liquid Specific Protein Controls
EA001 Elisa Diluent Wash Buffer
SC019 Microtitre Plates
SC020 Conjugate Solution
TMB005 One Shot Substrate
EA022 Elisa Stop Solution
Atellica CH Prealbumin (PreAlb)
ADVIA Chemistry XPT Prealbumin (PREALB)
RANDOX PREALBUMIN
Prealbumin (PREALB) Reagents
Randox HbA1c Control level 1 and level 2
RANDOX GLYCEROL (GLY)
RANDOX TRIGLYCERIDES (TRIGS)
RANDOX TRIGLYCERID
RANDOX TRIGLYCERIDE
ADVIA Chemistry XPT Complement C3 (C3)
RANDOX COMPLEMENT C3
Complement C3 (C3) Reagents
Randox Cardiac Controls
Atellica CH Glucose Oxidase (GluO)
Randox CRP Immunoturbidimetric kit
RANDOX APOUPOPROTEIN A1 TEST
RANDOX APOLIPOPROTEIN AI
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
LIQUID RANBUT (RBT)
RANBUT
Triglycerides (TRIG) Reagents
Randox Triglycerides
RANDOX PHENYTOIN
CHOLRIDE ELECTRODE (I.S.E. Cl)
SODIUM ELECTRODE (I.S.E. Na)
POTASSIUM ELECTRODE (I.S.E. K)
RANDOX APOLIPOPROTEIN A-II (APO A-II)
RANDOX APOLIPOPROTEIN C-II (APO C-II)
APOLIPOPROTEIN A-I (APO A-I)
APOLIPOPROTEIN B (APO B)
RANDOX APOLIPOPROTEIN C-III (APO C-III)
RANDOX Apolipoprotein E (Apo E)
Vancomycin
RANDOX CARBAMAZEPINE
RANDOX MAGNESIUM
ADVIA Chemistry XPT Digoxin (DIG)
Atellica CH Digoxin (Dgn)
Randox Digoxin
Randox RX Daytona Plus Alkaline Phosphatase (ALP)
Randox C.S.F. Controls Levels 2 and 3
Atellica CH Aspartate Aminotransferase P5P (ASTPLc)
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)
Direct HDL Cholesterol (HDL)
ADVIA Chemistry XPT Direct HDL Cholesterol (D-HDL)
Atellica CH Direct HDL Cholesterol (D-HDL)
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
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
RANDOX CO2 (TOTAL)
Randox CK-NAC Activated
Ammonia Ethanol Control Level 1
Ammonia Ethanol Control Level 2
Ammonia Ethanol Control Level 3
RANDOX LD opt. (LDH P-L)
Atellica CH Lactate Dehydrogenase L-P (LDLP)
RANDOX URINE CONTROLS
RANDOX SODIUM
Total Bilirubin (TBIL)
Therapeutic Drug Monitoring Linearity Verifiers
Liquid Specific Protein Calibrators
RANDOX B2Microglobulin (B2M)
Atellica CH ?2-Microglobulin (B2M)
Randox Calibration Serum
RANDOX APOLIPOPROTEIN
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility