RANDOX LABORATORIES LIMITED

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3004493545	3004493545	RANDOX LABORATORIES LIMITED	1	N	2026-01-01	36 / 44 LARGY ROAD CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey GB BT29 4RN

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
05055273200560	AMY - The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.	+442894451070	technical.services@randox.com
05055273200577	AMY - The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.	+442894451070	technical.services@randox.com
05055273200584	AMY - The AMY method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of amylase activity in serum, plasma and urine.	+442894451070	technical.services@randox.com
05055273200591	P AMY - A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or urine.	+442894451070	technical.services@randox.com
05055273200607	AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.	+442894451070	technical.services@randox.com
05055273200614	P AMY - A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or urine.	+442894451070	technical.services@randox.com
05055273200645	AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.	+442894451070	technical.services@randox.com
05055273200652	AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, or urine.	+442894451070	technical.services@randox.com

randox.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
9803	1030178974	K984494	RANDOX ALBUMIN	CIX	1999-03-23
9803	1723354791	K982529	RANDOX DIRECT LDL CHOLESTEROL	MRR	1998-09-11
9803	2029138692	K982341	DIRECT HDL-CHOLESTROL LIQUID	LBS	1998-07-30
9803	1894519774	K974607	RANDOX CALCIUM	CJY	1998-02-02
9803	1653053841	K974606	RANDOX MAGNESIUM	JGJ	1998-02-12
9803	1803519196	K974605	RANDOX INORGANIC PHOSPHOROUS	CEO	1998-01-09
9803	1764058041	K974604	RANDOX IRON	JMO	1998-01-06
9803	1687590448	K973995	RANDOX BILIRUBIN	GIG	1997-12-08
9803	1305189110	K973993	RANDOX CREATININE	CGX	1998-03-06
9803	1122590769	K972608	RANDOX ASSAYED SPECIFIC PROTEIN CONTROL	JJY	1997-08-04
9803	1146428148	K972220	RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT	DHR	1997-09-09
9803	1095789950	K971825	PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST	JFJ	1997-07-24
9803	1617264246	K970735	BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL	LBS	1997-06-06
9803	1563167068	K970684	LACTATE DEHYDROGENASE (LD)	CFJ	1997-05-07
9803	1329484951	K961169	RHEUMATOID FACTOR LATEX SLIDE TEST KIT	DHR	1996-06-26
9803	1362600465	K955798	IGG IMMUNOTURBIDIMETRIC & CALIBRATOR	DEW	1996-04-05
9803	1095316000	K955797	IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR	DFT	1996-04-05
9803	1376225420	K955794	IGA IMMUNOTURBIDIMETRIC & CALIBRATOR	CZP	1996-04-05
9803	2032068830	K955087	HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS	LCP	1996-06-13
9803	1901566635	K954447	C-REACTIVE PROTEIN LATEX KIT	DCK	1995-12-18
9803	1412715296	K953212	C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR	DCK	1995-07-31
9803	1998801670	K953211	AMYLASE (ETHYLIDENE PNGPG7) KIT	CIJ	1996-06-21
9803	1301549672	K953210	GLUCOSE (HEXOKINASE) KIT	CFR	1996-10-25
9803	1741146475	K951223	CK-MB (NAC-ACT)	CGS	1995-12-26
9803	1431286099	K951222	TOTAL PROTEIN (URINE)	JIR	1996-04-24
9803	1649698631	K951221	TOTAL CO2	KHS	1996-02-15
9803	1052535471	K950383	APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT	JHN	1995-09-15
9803	1872776248	K950382	APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT	JHN	1995-09-15
9803	1975052643	K942458	PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED	JJY	1995-03-13
9803	1722166384	K923511	CK-NAC ACTIVATED KIT	CGS	1992-10-15
9803	1888295070	K923510	ALT (GPT) - ALANINE AMINOTRANSFERASE	CKA	1992-11-16
9803	1438009303	K923509	GAMMA-GT	JPZ	1992-12-03
9803	2015610211	K923508	TRIGLYCERIDES GPO-PAP	CDT	1993-07-28
9803	1894705124	K923507	ALKALINE PHOSPHATASE KIT	CJE	1992-12-03
9803	1922240135	K923506	UREA KIT	CDQ	1993-09-27
9803	1757492662	K923505	AST (GOT) - ASPARTATE AMINOTRANSFERASE	CIT	1992-11-16
9803	1916029492	K923504	CHOLESTEROL ENZYMATIC ENDPOINT	CHH	1994-01-10
9803	1829702951	K923503	URIC ACID ENZYMATIC COLORIMERIC KIT	KNK	1993-07-22
9803	1282590160	K882038	GDS ENZYMATIC SALICYLATE REAGENT	DKJ	1988-06-24
9803	1976270691	K881040	EMIT VANCOMYCIN ASSAY	LEH	1988-04-19
9803	1678829167	K880829	GDS ENZYMATIC ACETAMINOPHEN REAGENT	LDP	1988-05-27
9803	1195478954	K250741	Evidence MultiSTAT DOA Urine MultiPlex	DJG	2026-01-23
9803	1074167777	K230890	ISE Electrodes	CEM	2023-09-08
9803	1890859431	K221550	Evidence MultiSTAT DOA Urine MultiPlex	DJG	2023-10-05
9803	1182474328	K220451	Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT	DJG	2023-10-05
9803	1561782656	K182042	Randox Calcium (Ca)	CJY	2018-10-23
9803	1644883084	K162275	Randox RX Daytona Plus Alkaline Phosphatase (ALP)	CJE	2017-04-21
9803	1337192142	K162200	Randox RX Daytona Plus Magnesium (MG)	JGJ	2017-04-28
9803	1320342339	K161691	Direct LDL Cholesterol (LDL)	MRR	2017-03-20
9803	1633183949	K153435	Direct HDL Cholesterol (HDL)	LBS	2016-01-08
9803	1863352776	K152344	Total Bilirubin	JFM	2016-01-28
9803	1945825934	K152343	Direct Bilirubin	JFM	2016-02-16
9803	1973009873	K152085	Liquid CO2-2 (LCO2-2)	KHS	2016-02-24
9803	1948974370	K150819	Triglycerides	CDT	2015-08-06
9803	1212336019	K150654	Cholesterol	CHH	2015-09-29
9803	1019236395	K142181	RANDOX ALDOLASE CALIBRATION SERUM	JIT	2014-09-18
9803	1815870626	K140971	LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.	JJY	2014-12-08
9803	1490278324	K140522	RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL	JJY	2014-05-22
9803	1097634252	K140393	RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3	JJY	2014-03-25
9803	1193913431	K132156	RANDOX CSF CONTROLS LEVELS 2 AND 3	JJY	2013-10-23
9803	1733458388	K132090	BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2	DLJ	2013-08-08
9803	1076724026	K131999	HBA1C CONTROL, LEVEL 1 AND LEVEL 2	JJX	2013-07-26
9803	1709548611	K131776	ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3	JJX	2013-07-18
9803	1962659774	K131554	RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT	JJE	2014-01-09
9803	1913405903	K130337	RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3	JJY	2013-06-19
9803	1292573404	K123977	RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR	CGS	2013-11-21
9803	1047871297	K122599	ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR	DDR	2012-10-03
9803	1092894479	K122126	DIRECT LDL/HDL CHOLESTEROL CALIBRATOR	JIS	2012-08-14
9803	1467335652	K121746	RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)	JJX	2012-07-11
9803	1225721426	K121603	RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3	JJY	2012-11-20
9803	1643239443	K121588	RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3	JJX	2012-06-20
9803	1423967116	K113751	RANDOX COCAINE METABOLITE	DIO	2012-05-08
9803	1234316153	K113747	RANDOX OPIATES ASSAY	DJG	2012-08-24
9803	1164770661	K113720	RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3	JJY	2012-09-20
9803	1609455830	K112337	RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL	JJY	2011-12-01
9803	1904388638	K110904	RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3	JJY	2011-09-30
9803	1271393545	K110846	RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2	JJW	2011-09-30
9803	1410351700	K110736	ADVIA CHEMISTRY FERRITIN (FRT) METHOD	DBF	2011-08-17
9803	1835497293	K110534	RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3	JJY	2012-01-23
9803	1264124188	K110188	DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT	LCP	2011-05-17
9803	1377206018	K103701	ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS	JIX	2011-02-18
9803	1373744677	K102346	RANDOX DIGOXIN ASSAY	KXT	2011-10-14
9803	1791636328	K093384	MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)	JJY	2010-03-10
9803	1920793747	K092275	RANDOX ECSTASY (MDMA) ASSAY	DKZ	2011-03-01
9803	2017566428	K092274	RANDOX BENZODIAZEPINE ASSAY	JXM	2010-10-15
9803	1040252582	K092273	RANDOX ETHANOL ASSAY	DIC	2010-11-01
9803	1238240249	K092272	RANDOX METHADONE ASSAY	DJR	2010-11-18
9803	1045888514	K092269	CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET	LDJ	2011-04-08
9803	1363467612	K092268	RANDOX BARITURATES ASSAY	DIS	2011-05-25
9803	1269223922	K092266	RANDOX METHAMPHETAMINE ASSAY	DKB	2011-05-09
9803	1926062281	K092258	RANDOX METABOLITE (EDDP) ASSAY	DJR	2010-11-09
9803	1028956050	K083906	ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487	NDY	2009-03-11
9803	1440120447	K083386	ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)	CJY	2009-04-02
9803	1593983966	K083222	AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100	LPS	2009-07-31
9803	1910379448	K080973	CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC	JJY	2008-06-02
9803	1815847769	K072204	ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS	JIX	2007-10-05
9803	1894422240	K063845	ADVIA CHEMISTRY TOTAL BILIRUBIN_2	JFM	2007-12-07
9803	1928786310	K061056	RANDOX LIQUID PROTEIN CALIBRATOR	JIX	2006-07-20
9803	1449799540	K053153	RANDOX CALIBRATION SERUM	JIX	2006-01-13
9803	1050431144	K053132	WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791	JFM	2005-12-30
9803	1207598659	K052914	RX IMOLA	CEM	2006-03-31
9803	1764467669	K050374	ADVIA IMS LITHIUM ASSAY	NDW	2005-06-15
9803	1195296251	K050179	RANDOX BENZODIAZEPINE CLASS ASSAY	JXM	2005-05-17
9803	1819534665	K043268	SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2	CEI	2005-02-15
9803	1698744733	K043267	POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2	CEJ	2005-02-10
9803	1678726627	K043266	RANDOX URINE CONTROLS	JJW	2005-02-15
9803	1883085181	K043071	RANDOX PHENCYCLIDINE ASSAY	LCM	2005-01-27
9803	1737417363	K042448	DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT	JJX	2004-10-29
9803	1261347150	K041898	CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM	JJX	2004-08-16
9803	1568874239	K041361	RANDOX TRI LEVEL CARDIAC CONTROL	JJY	2004-09-09
9803	1035097627	K041144	RANDOX OPIATES ASSAY	DJG	2004-11-03
9803	1399266273	K041143	RANDOX BARBITURATE ASSAY	DIS	2004-11-05
9803	1987306844	K041142	RANDOX CANNABINOIDS ASSSAY	LDJ	2004-11-23
9803	1593612356	K040927	LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS	JJX	2004-05-17
9803	1604415854	K040570	RANDOX METHADONE ASSAY	DJR	2004-05-10
9803	2051713670	K040379	RANDOX IMMUNOASSAY CONTROL	JJY	2004-06-16
9803	1278758130	K040351	RANDOX LIQUID CRP CONTROLS	JJX	2004-03-12
9803	1920440867	K040350	RANDOX AMPHETAMINE CLASS ASSAY	DKZ	2004-05-12
9803	1864813501	K033884	RANDOX AMIKACIN	KLQ	2004-06-09
9803	1968352543	K033360	DIAZYME LITHIUM ENZYMATIC ASSAY KIT	JII	2003-12-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JJY	21	2014-12-08
JJX	8	2013-07-26
JIX	6	2011-02-18
DJG	5	2026-01-23
LCP	5	2011-05-17
JFM	4	2016-02-16
CJY	3	2018-10-23
LBS	3	2016-01-08
CGS	3	2013-11-21
JIS	3	2012-08-14
DJR	3	2010-11-18
DCK	3	2000-08-04
CEM	2	2023-09-08
JGJ	2	2017-04-28
CJE	2	2017-04-21
MRR	2	2017-03-20
KHS	2	2016-02-24
CHH	2	2015-09-29
CDT	2	2015-08-06
DDR	2	2012-10-03
DIO	2	2012-05-08
KXT	2	2011-10-14
JJW	2	2011-09-30
DBF	2	2011-08-17
DIS	2	2011-05-25
LDJ	2	2011-04-08
DKZ	2	2011-03-01
JXM	2	2010-10-15
CGA	2	2003-12-04
JIF	2	2003-05-12
JMO	2	2000-05-02
DHR	2	1997-09-09
JHN	2	1995-09-15
SES	1	2025-05-22
JIT	1	2014-09-18
JJE	1	2014-01-09
DLJ	1	2013-08-08
DKB	1	2011-05-09
DIC	1	2010-11-01
LPS	1	2009-07-31

PMN#

Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
2023-10-05
Randox Laboratories Limited
Evidence MultiSTAT DOA Urine MultiPlex
2023-10-05
Randox Laboratories Limited
Randox RX Daytona Plus Alkaline Phosphatase (ALP)
2017-04-21
RANDOX LABORATORIES LIMITED
Direct LDL Cholesterol (LDL)
2017-03-20
RANDOX LABORATORIES LIMITED
Direct Bilirubin
2016-02-16
RANDOX LABORATORIES LIMITED
Total Bilirubin
2016-01-28
RANDOX LABORATORIES LIMITED
Triglycerides
2015-08-06
Randox Laboratories Limited
LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
2014-12-08
RANDOX LABORATORIES LIMITED
RANDOX ALDOLASE CALIBRATION SERUM
2014-09-18
RANDOX LABORATORIES LIMITED
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
2014-05-22
RANDOX LABORATORIES LIMITED
RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
2014-03-25
RANDOX LABORATORIES LIMITED
RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
2013-06-19
RANDOX LABORATORIES LIMITED
RANDOX OPIATES ASSAY
2012-08-24
RANDOX LABORATORIES LIMITED
DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
2012-08-14
RANDOX LABORATORIES LIMITED
RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
2012-01-23
RANDOX LABORATORIES LIMITED
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
2011-09-30
RANDOX LABORATORIES LIMITED
RANDOX TRI LEVEL CARDIAC CONTROL
2004-09-09
RANDOX LABORATORIES LIMITED

GUDID#

AMY - The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
2016-09-09
AMY - The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
2016-09-09
AMY - The AMY method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of amylase activity in serum, plasma and urine.
RANDOX LABORATORIES LIMITED
2016-09-09
P AMY - A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
2016-09-09
AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
2016-09-09
P AMY - A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
2016-09-09
AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
2016-09-09
AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, or urine.
RANDOX LABORATORIES LIMITED
2016-09-09
P AMY - The device is intended for the quantitative in vitro determination of pancreatic α amylase in serum, plasma and urine.
RANDOX LABORATORIES LIMITED
2016-09-09
AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
2016-09-09
BIOHACKER Premium Home Blood Sampling Collection Kit - The Biohacker (Premium Home Blood Sampling Collection Kit) is intended for use in the collection and transport of a capillary blood samples for use in biochemical laboratory analysis. This device is intended for sample collection purposes only. Samples may be collected at home through adherence to the Instructions for Use (IFU) or may be collected under the guidance of a medical professional.
RANDOX LABORATORIES LIMITED
2026-05-22
MALE HORMONE Premium Home Blood Sampling Collection Kit - The Male Hormone (Premium Home Blood Sampling Collection Kit) is intended for use in the collection and transport of a capillary blood samples for use in biochemical laboratory analysis. This device is intended for sample collection purposes only. Samples may be collected at home through adherence to the Instructions for Use (IFU) or may be collected under the guidance of a medical professional.
RANDOX LABORATORIES LIMITED
2026-05-22
BASELINE Venous Sample Collection kit - The Baseline (Venous Sample Collection Kit) is intended for use in the collection and transportation of a blood sample taken by trained phlebotomist for use in biochemical laboratory analysis. This device is intended for sample collection purposes only. The sample will be collected in a home and/or clinical environment and transported to a professional laboratory for analysis.
RANDOX LABORATORIES LIMITED
2026-05-22
FEMALE HORMONE Premium Home Blood Sampling Collection Kit - The Female Hormone (Premium Home Blood Sampling Collection Kit) is intended for use in the collection and transport of a capillary blood samples for use in biochemical laboratory analysis. This device is intended for sample collection purposes only. Samples may be collected at home through adherence to the Instructions for Use (IFU) or may be collected under the guidance of a medical professional.
RANDOX LABORATORIES LIMITED
2026-05-22
BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit - The Baseline Self-Draw (Premium Home Blood Sampling Collection Kit) is intended for use in the collection and transport of a capillary blood samples for use in biochemical laboratory analysis. This device is intended for sample collection purposes only. Samples may be collected at home through adherence to the Instructions for Use (IFU) or may be collected under the guidance of a medical professional.
RANDOX LABORATORIES LIMITED
2026-05-22
COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) - CG5021
RANDOX LABORATORIES LIMITED
2019-06-03
COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2) - CG5022
RANDOX LABORATORIES LIMITED
2019-06-03
COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3) - CG5023
RANDOX LABORATORIES LIMITED
2019-06-03
COAGULATION CALIBRATOR (COAG CAL) - CG5037
RANDOX LABORATORIES LIMITED
2019-06-03
APOLIPOPROTEIN E (APO E) - LP3864
RANDOX LABORATORIES LIMITED
2019-06-03
ALB - An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma.
RANDOX LABORATORIES LIMITED
2016-09-16
ALB - An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma.
RANDOX LABORATORIES LIMITED
2016-09-16
ALB - An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma.
RANDOX LABORATORIES LIMITED
2016-09-16
ALB - An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum.
RANDOX LABORATORIES LIMITED
2016-09-16
ConcizuTrace™ ELISA - The ConcizuTrace™ ELISA device is for use in determining the concentration of the drug, concizumab, in 3.2% citrated plasma from patients with Haemophilia A & B, with and without inhibitors, who are undergoing treatment with concizumab for routine prophylaxis of bleeding episodes. The device is a sandwich ELISA. The intended users are trained laboratory professionals.
RANDOX LABORATORIES LIMITED
2025-05-30
GLUTATHIONE REDUCTASE (GLUT RED) - GR2368
RANDOX LABORATORIES LIMITED
2019-06-03
GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL) - GR2608
RANDOX LABORATORIES LIMITED
2019-06-03
GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL) - GR2609
RANDOX LABORATORIES LIMITED
2019-06-03
RABS - The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system.
RANDOX LABORATORIES LIMITED
2016-09-26
RX daytona - RX Daytona is an automated clinical chemistry analyser complete with dedicated analyser software.
RANDOX LABORATORIES LIMITED
2018-06-07
WASH conc. 3 - Cleaning Solution for the RX series analysers
RANDOX LABORATORIES LIMITED
2016-09-26
CAL B - The product is intended to be used as a second Calibrator in a two-point calibration. Calibrator B is aspirated from a sample cup at position 18 on the analyser ASP tray at least once every 8 hours depending on the laboratories schedule.
RANDOX LABORATORIES LIMITED
2016-09-26
ISE DIL URN - The product is required for urine samples. Urine samples must be diluted by a factor of 10 to perform urine measurement. The host analyser will mix the diluent and sample before dispensing the diluted sample into the ISE module.
RANDOX LABORATORIES LIMITED
2016-09-26
WASH conc. 2 - Cleaning Solution for the RX series analysers
RANDOX LABORATORIES LIMITED
2016-09-26
WASH conc. 1 - Cleaning Solution for the RX series analysers
RANDOX LABORATORIES LIMITED
2016-09-26
Cl SOLN - Cleaning Solution for the RX series analysers
RANDOX LABORATORIES LIMITED
2016-09-26
CAL A - The product is intended to be used as a wash solution and single point calibrator. Calibrator A is pumped into the sample port by the Calibrator A pump and then positioned in front of the sensor.
RANDOX LABORATORIES LIMITED
2016-09-26
RX imola - Rx Imola is an automated clinical chemistry analyser complete with dedicated analyser software.
RANDOX LABORATORIES LIMITED
2018-06-07
NS - This product should be used in conjunction with RX series reagents to dilute samples prior to assay
RANDOX LABORATORIES LIMITED
2016-09-26
SABS - This product is used for checking proper functioning of the sample fluid metering system as well as the photometric measuring system.
RANDOX LABORATORIES LIMITED
2016-09-26

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