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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 6 of 12

Device	Model / Reference	Registries	Class	Status
Chemistry Premium - Level 2 (chem Premium 2)	HN5067	FDA UDI	Class I	Active
Alt	AL3875	FDA UDI	Class I	Active
Fe	SI257	FDA UDI	Class I	Active
Fruc	FR3133	FDA UDI	Class II	Active
D Bil	BR8308	FDA UDI	Class II	Active
Amh Control Level 1 (amh Control 1)	AMH10509	FDA UDI	Class I	Active
Anti-Streptolysin-O 2 (aso 2)	LO8305	FDA UDI	Class I	Active
Thc Control 1	DA3127	FDA UDI	Class I	Active
Bil	BR411	FDA UDI	Class II	Active
Liquid Frozen Lipid Control - Level 1 (liq Lpd Control 1)	LE10174	FDA UDI	Class I	Active
Haematology Control - Level 1 (haem Cntl - Level 1)	HM10190	FDA UDI	Class II	Active
MAGNESIUM (Mg)	MG3880	FDA UDI	Class I	Active
Ldh	LD2812	FDA UDI	Class II	Active
Alanine Aminotransferase (alt)	AL8304	FDA UDI	Class I	Active
Inorganic Phosphorous (phos)	PH8048	FDA UDI	Class I	Active
Bun	UR2821	FDA UDI	Class II	Active
Mdma	DA4014	FDA UDI	Class II	Active
Gamma-Glutamyltranserase (ggt)	GT8320	FDA UDI	Class I	Active
Lipase (lps)	LI8050	FDA UDI	Class I	Active
IgA	IA2447	FDA UDI	Class II	Unknown
Cal 2	CAL2350	FDA UDI	Class II	Active
Direct Ldl-Cholesterol (ldl)	CH2656	FDA UDI	Class I	Active
mALB	MA8325	FDA UDI	Class II	Active
Total Iron-Binding Capacity 2 (tibc_2)	TI4064	FDA UDI	Class I	Active
Direct Bilirubin 2 (d Bil 2)	BR8376	FDA UDI	Class II	Active
Urea	UR457	FDA UDI	Class II	Active
Randox Evidence™	EV3600	FDA UDI	Class I	Active
Urea	UR446	FDA UDI	Class II	Active
Theo	TD3412	FDA UDI	Class II	Unknown
Gluc-Pap	GL2623	FDA UDI	Class II	Active
Ca	CA2807	FDA UDI	Class II	Active
Cytokine Controls (ctk Control)	CY5006	FDA UDI	Class I	Active
Opiat	DA4012	FDA UDI	Class II	Active
Hdl-Cholesterol (hdl)	CH203	FDA UDI	Class I	Active
Crp	CP7950	FDA UDI	Class II	Active
ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE)	LV10366	FDA UDI	Class I	Active
Inorganic Phosphorous (phos)	PH8328	FDA UDI	Class I	Active
Liquid Cardiac Control 2	CQ10535	FDA UDI	Class I	Active
IRON (Fe)	SI8049	FDA UDI	Class I	Active
CO2/ELECTROLYTE LINEARITY VERIFIERS (For Roche Systems) (CO2 LIN VER)	LV10362	FDA UDI	Class I	Active
Liquid Assayed Chemistry Control Premium – Level 3 (liq Chem Asy Premium 3)	LAE4217	FDA UDI	Class I	Active
Uric Acid (ua)	UA3870	FDA UDI	N/A	Active
Immunoassay Premium Plus - Tri-Level (ia Premium Plus 1, 2 And 3)	IA3112	FDA UDI	Class I	Active
T Bil	BR3859	FDA UDI	Class II	Active
Apo B	LP2990	FDA UDI	Class I	Active
L Soln	RX4044	FDA UDI	Class I	Active
Ck-Nac	CK7947	FDA UDI	Class II	Active
Total Iron-Binding Capacity 2 (tibc_2)	TI8375	FDA UDI	Class I	Active
Potassium (K)	PT3852	FDA UDI	Class II	Active
BILIRUBIN LINEARITY VERIFIER (For Roche Systems) (BILIRUBIN LIN VER ROCHE)	LV10356	FDA UDI	Class I	Active

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