Is this your brand? Sign in to claim ownership.

RANDOX LABORATORIES LIMITED

Northern Ireland·XI-MF-000028410

Last updated May 24, 2026

What RANDOX LABORATORIES LIMITED makes

Randox Laboratories Limited manufactures a range of laboratory consumables and controls for clinical diagnostics, including liquid chemistry controls, immunoassay controls, serology controls, and microbiome sample collection kits. Their products also cover wash buffers, acid wash solutions, and customizable controls for therapeutic drug monitoring and specific assays like BNP and ToRCH IgM testing. The company provides both standard and bespoke solutions for diagnostic laboratories, such as the Randox Discovery system and specialized reagents for immunoassays.

The company’s portfolio includes devices classified under EU Class A, B, and C, as well as FDA Class I and II, reflecting a mix of low-risk and moderate-risk medical devices. Their products are registered in the EU’s EUDAMED database and the FDA’s 510(k) premarket notification system, indicating compliance with European and US regulatory requirements. The manufacturer operates from the UK.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Northern Ireland
Address: 55, Diamond Road, Crumlin, Northern Ireland
Website: randox.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +442894422413
PRRC Contact: Louise Boyle
EUDAMED SRN: XI-MF-000028410
FDA FEI Number: —
DUNS Number: 227530649

Catalogue (180)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Lipid Control - Level 1 (lpd Control 1)	LE2661	EUDAMEDFDA UDI	Class B	Active
WASH BUFFER CONCENTRATE (BUF WASH (conc.))	EV3581	EUDAMEDFDA UDI	Class A	Active
Liquid Chemistry Premium Plus - Level 3 (liq Chem Premium Plus 3)	LUE5071	EUDAMEDFDA UDI	Class B	Active
Bnp Controls For Beckman (bnp Control)	CQ10520	EUDAMEDFDA UDI	Class B	Active
Microbiome Home Sample Collection Kit	SCK10665	EUDAMED	Class A	Active
Randox Discovery	RDC10000	EUDAMED	Class A	Active
Custom Liquid Chemistry Control Level 3	LUE5169	EUDAMED	Class B	Active
SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +)	SR10349	EUDAMEDFDA UDI	Class B	Active
Liquid Immunoassay Control - Level 2 (IA CONTROL 2)	LIA5143	EUDAMEDFDA UDI	Class B	Active
Serology I Positive Control (serology I Control Positive)	SR10352	EUDAMEDFDA UDI	Class B	Active
Custom Liquid Therapeutic Drug Control - Level 2	HD3146	EUDAMED	Class B	Active
Acid Wash Solution (aws)	WS3853	EUDAMEDFDA UDI	Class A	Active
Serology Ii Positive Control (serology Ii Control Positive)	SR10353	EUDAMEDFDA UDI	Class B	Active
Venous Blood Sample Collection Kit 2	SCK10695	EUDAMED	Class A	Active
Liquid Chemistry Premium Plus - Level 1 (liq Chem Premium Plus 1)	LUL5069	EUDAMEDFDA UDI	Class B	Active
Parathyroid Hormone Control - Level 3 (pth Control 3)	PTH10610	EUDAMEDFDA UDI	Class B	Active
Custom Liquid Chemistry Control Level 2	LUN5168	EUDAMED	Class B	Active
Xanthochromia Positive Control (xanthochromia Control +)	XN10505	EUDAMEDFDA UDI	Class B	Active
Apolipoprotein Calibrator (apo Cal)	LP3023	EUDAMEDFDA UDI	Class B	Active
Bnp Controls For Abbott (bnp Control)	CQ10521	EUDAMEDFDA UDI	Class B	Active
Serology Negative Control (serology Control Negative)	SR10351	EUDAMEDFDA UDI	Class B	Active
Cardiac Control – Level 1 (crd Control 1)	CQ10429	EUDAMEDFDA UDI	Class B	Active
AMMONIA ETHANOL CONTROL - LEVEL 3 (NH3/EtOH CONTROL 3)	EA1368	EUDAMEDFDA UDI	Class B	Active
Venous Blood Sample Collection Kit 3	SCK10696	EUDAMED	Class A	Active
SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -)	SR10347	EUDAMEDFDA UDI	Class B	Active
Custom Liquid Immunoassay Control - Level 2	LIA3149	EUDAMED	Class B	Active
PRE-ECLAMPSIA CONTROL LEVEL 3 (Pre-eclampsia CONTROL 3)	PE10529	EUDAMEDFDA UDI	Class C	Active
Total Antioxidant Status (tas Control)	NX2331	EUDAMEDFDA UDI	Class B	Active
Direct Bilirubin	K152343	FDA 510(k)	Class II	Active
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT	K220451	FDA 510(k)	Class II	Active
Triglycerides	K150819	FDA 510(k)	Class I	Active
Randox Speciality Control (i) Levels 1, 2 And 3	K130337	FDA 510(k)	Class I	Active
Evidence MultiSTAT DOA Urine MultiPlex	K250741	FDA 510(k)	Class II	Active
Randox Ammonia Ethanol Control Levels 1, 2 And Level 3	K140393	FDA 510(k)	Class I	Active
Randox Opiates Assay	K113747	FDA 510(k)	Class II	Active
Randox Liquid Cardiac Control Levels 1, 2 And 3	K110534	FDA 510(k)	Class I	Active
Total Bilirubin	K152344	FDA 510(k)	Class II	Active
Randox Immunoassay Premium Plus Control Levels 1, 2 And Level 3 And Immunoassay Premium Plus Tri-Level Control	K140522	FDA 510(k)	Class I	Active
Evidence MultiSTAT DOA Urine MultiPlex	K221550	FDA 510(k)	Class II	Active
Randox Tri Level Cardiac Control	K041361	FDA 510(k)	Class I	Active
Liquid Assayed Chemistry Control Premium Plus Level 1, 2 And Level 3.	K140971	FDA 510(k)	Class I	Active
Randox RX Daytona Plus Alkaline Phosphatase (ALP)	K162275	FDA 510(k)	Class II	Active
Randox Urinalysis Controls, Levels 1 And 2	K110846	FDA 510(k)	Class I	Active
Cardiac Control - Level 1 (crd Control 1)	CQ10454	EUDAMED	Class B	Active
Aldolase And Glutathione Reductase Level 2 Control (als & Glut Red Control 2)	AGR10572	EUDAMED	Class B	Active
Csf Control - Level 3 (csf Control 3)	CF1501	EUDAMEDFDA UDI	Class B	Active
Signal Reagent – Ev840 (reag Sgnl – Ev840)	EV3717	EUDAMED	Class A	Active
LIPOPROTEIN (a) CALIBRATOR SERIES (Lp(a) CAL SET)	LP3404	EUDAMEDFDA UDI	Class B	Active
ConcizuTrace™ ELISA	CZM10591	EUDAMEDFDA UDI	Class C	Active
Parathyroid Hormone Control - Level 2 (pth Control 2)	PTH10609	EUDAMEDFDA UDI	Class B	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Randox Laboratories, Ltd. US