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Randox Laboratories, Ltd.

Last updated May 24, 2026

What Randox Laboratories, Ltd. makes

Randox Laboratories, Ltd. manufactures in vitro diagnostics (IVDs) for clinical chemistry, including reagent kits and controls for analytes like urea, glucose, conjugated bilirubin, C-reactive protein, total protein, alanine aminotransferase (ALT), and microalbumin. Their portfolio also includes liquid controls for glycated haemoglobin (HbA1c) and immunassay specialty controls for various diagnostic platforms. Spectrophotometry and nephelometry/turbidimetry methods are used in their product line.

The company’s devices are classified as Class I, Class II, or Unclassified (U) under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

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

Information

Country: US
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Catalogue (597)

Page 1 of 12

Device	Model / Reference	Registries	Class	Status
Immunoassay Speciality Ii - Level 3 (ia Speciality Ii Lev 3)	IAS3119	FDA UDI	Class I	Active
Human Assayed Multi-Sera/Assayed Chemistry Premium Plus - Level 2 (hum Asy Contr	HN1530	FDA UDI	Class I	Active
Ck-Mb	CK1553	FDA UDI	Class II	Active
Assayed Bovine Multi Sera - Level 2 (bov Asy Control 2)	AN1026	FDA UDI	Class I	Active
Immunoassay Speciality Ii - Level 1 (ia Speciality Ii Lev 1)	IAS3117	FDA UDI	Class I	Active
ESOTERIC LINEARITY VERIFIERS (For Roche Systems) (ESOTERIC LIN VER ROCHE)	LV10336	FDA UDI	Class I	Active
Liquid Glycated Haemoglobin (HbA1c) Control Level 2 (LIQ HbA1c CONTROL LEVEL 2)	HA10225	FDA UDI	Class I	Active
Liquid Immunoassay Premium - Tri-Level (liq Ia Premium 1, 2 And 3)	LIA3108	FDA UDI	Class I	Active
Alanine Aminotransferase (alt)	AL7904	FDA UDI	Class I	Active
Immunoassay Premium - Level 2 (ia Premium 2)	IA2639	FDA UDI	Class I	Active
Liquid Glycated Haemoglobin (HbA1c) Control Level 1 (LIQ HbA1c CONTROL LEVEL 1)	HA10224	FDA UDI	Class I	Active
Specific Protein Control - Level 3 (sp Control 3)	PS10223	FDA UDI	Class I	Active
Gluc-Hk	GL2822	FDA UDI	Class II	Active
L-Lactate (lac)	LC2389	FDA UDI	Class I	Active
Immunoassay Premium Plus - Level 1 (ia Premium Plus 1)	IA3109	FDA UDI	Class I	Active
Total Protein 2 (tp 2)	TP4001	FDA UDI	Class II	Active
Doa Cal	DA2704	FDA UDI	Class II	Active
Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3)	LAE10567	FDA UDI	Class I	Active
Cystatin C Control - Level 3 (cysc Control 3)	CYS10447	FDA UDI	Class I	Active
Potassium (K)	PT7168	FDA UDI	Class II	Active
IgA	IA7157	FDA UDI	Class II	Active
LD opt. (LDH P-L)	LD8322	FDA UDI	Class II	Active
Liquid Chemistry Premium - Level 2 (liq Chem Premium 2)	LUN5048	FDA UDI	Class I	Active
Direct Hdl-Cholesterol (hdl)	CH2655	FDA UDI	Class I	Active
SARS CoV-2 Controls (SARS-CoV-2)	COV10460	FDA UDI	Class I	Active
D Bil	BR2801	FDA UDI	Class II	Active
Bzg	DA4011	FDA UDI	Class II	Active
Aldolase (als)	AD189	FDA UDI	Class I	Active
Hdl	CH3811	FDA UDI	Class I	Active
Chemistry Premium - Level 3 (chem Premium 3)	HE5068	FDA UDI	Class I	Active
Coagulation Calibrator (coag Cal)	CG5037	FDA UDI	Class II	Active
Total Protein 2 (tp 2)	TP8066	FDA UDI	Class II	Active
RHEUMATOID FACTOR LINEARITY VERIFIERS (For Roche Systems) (RFLV)	LV10343	FDA UDI	Class I	Active
Assayed Bovine Multi Sera - Level 1 (bov Asy Control 1)	AL1027	FDA UDI	Class I	Active
Blood Gas Control - Level 1 (bg Control 1)	BG5001	FDA UDI	Class I	Active
Doa	EV3500	FDA UDI	U	Active
D Bil	BR2362	FDA UDI	Class II	Active
mALB	MA2864	FDA UDI	Class II	Active
Crp	CP3826	FDA UDI	Class II	Active
Haematology Control - Level 2 (haem Cntl - Level 2)	HM10191	FDA UDI	Class II	Active
Mdone	DA4016	FDA UDI	Class II	Active
Gluc-Hk	GL3881	FDA UDI	Class II	Active
Alt	AL3801	FDA UDI	Class I	Active
Cholesterol (chol)	CH8019	FDA UDI	Class I	Active
Thc	DA4010	FDA UDI	Class II	Active
Alp	AP3877	FDA UDI	Class II	Active
Alkaline Phosphatase (alp)	AP8302	FDA UDI	Class II	Active
IgE	IE7308	FDA UDI	Class II	Active
Alp	AP7927	FDA UDI	Class II	Active
H Soln	RX4046	FDA UDI	Class I	Active

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