FDA Registration
Active
🇬🇧 United Kingdom
RANDOX LABORATORIES LIMITED
Reg #: 3014607865
·
FEI: 3014607865
·
Expires 2026
Products
32
Proprietary Names
201
Establishment Types
4
Classifications
32
Registration Details
- Registration Name
- RANDOX LABORATORIES LIMITED
- Registration Number
- 3014607865
- FEI Number
- 3014607865
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 30 RANDALSTOWN ROAD
- City
- ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K250741
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 |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2018-06-18 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2012-12-21 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2012-12-21 |
| Albumin, Fitc, Antigen, Antiserum, Control | DDZ | Class 2 | Immunology | No | 2000-10-18 |
| 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, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2026-01-27 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2026-01-27 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2026-01-27 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2026-01-27 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2026-01-27 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2026-01-27 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2026-01-27 |
| Non-Factor Replacement Product Test System | SES | Class 2 | Hematology | No | 2025-05-29 |
| 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 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2011-08-03 |
| 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 |
| Lipoprotein, Low-Density, Antigen, Antiserum, Control | DFC | Class 2 | Immunology | No | 2013-01-07 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2008-02-05 |
| Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | LKL | Class 1 | Immunology | No | 2013-01-03 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2024-09-30 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | Class 1 | Immunology | No | 2000-09-22 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2019-07-31 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-02-16 |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2023-07-31 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2014-02-11 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2004-03-16 |
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
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
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
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)
RX IMOLA
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility