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Randox Laboratories, Ltd.

US

Last updated May 24, 2026

Part of Randox Laboratories Limited

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

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US
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Catalogue (597)

Page 7 of 12
DeviceModel / ReferenceRegistriesClassStatus
Liquid Chemistry Premium - Level 3 (liq Chem Premium 3) LUE5049
FDA UDI
Class IActive
Alp AP3802
FDA UDI
Class IIActive
Bilirubin Elevated Serum (bil Control H) BE454
FDA UDI
Class IActive
Sp Cal (liq) IT2691
FDA UDI
Class IIActive
Precision Check Solution (prec) RX8142
FDA UDI
Class IActive
Liquid Bilirubin Control - Level 1 (liq Bil Control 1) BR10172
FDA UDI
Class IActive
I.s.e. Cl D200-0016
FDA UDI
Class IIActive
Liquid Ranbut (rbt) RB8378
FDA UDI
Class IActive
Direct Hdl-Cholesterol (hdl) CH8311
FDA UDI
Class IActive
C4 CM3846
FDA UDI
Class IIActive
Gluc-Pap GL366
FDA UDI
Class IIActive
Ca CA590
FDA UDI
Class IIActive
Adiponectin Control - Level 3 (adpn Control 3) AO2802
FDA UDI
N/AActive
Apolipoprotein B (apo B) LP8008
FDA UDI
Class IActive
COPPER (Cu) CU2340
FDA UDI
Class IActive
Ransod Control SD126
FDA UDI
Class IActive
Ck CK2813
FDA UDI
Class IIActive
Direct Hdl-Cholesterol (hdl) CH1383
FDA UDI
Class IActive
Ck-Mb Cal CK2393
FDA UDI
Class IIActive
Glutathione Reductase (glut Red) GR2368
FDA UDI
Class IIActive
Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) LAL10565
FDA UDI
Class IActive
Sp Control 3 PS2684
FDA UDI
Class IActive
Fruc Control 1 FR2994
FDA UDI
Class IActive
Crea CR7948
FDA UDI
Class IIActive
PlaySafe™ SCK10690
FDA UDI
Class IActive
Ast AS1202
FDA UDI
Class IIActive
Co2 CD127
FDA UDI
Class IIActive
Triglycerides (trigs) TR3823
FDA UDI
N/AActive
HIGH SENSITIVITY CRP CONTROL - LEVEL II (hsCRP CONTROL 2) CP2477
FDA UDI
Class IActive
T Bil BR2361
FDA UDI
Class IIActive
Liquid Frozen Bilirubin Control - Level 1 (liq Bil Control 1) BR10442
FDA UDI
Class IActive
Co2 CD7942
FDA UDI
Class IIUnknown
Aspartate Aminotransferase (ast) AS101
FDA UDI
Class IIActive
Direct Ldl-Cholesterol (ldl) CH8312
FDA UDI
Class IActive
D-3 Hydroxybutyrate (RANBUT) RB1008
FDA UDI
Class IActive
Liquid Bilirubin Control - Level 2 (liq Bil Control 2) BR10173
FDA UDI
Class IActive
Liquid Chemistry Premium Plus - Level 1 (liq Chem Premium Plus 1) LUL5093
FDA UDI
Class IActive
P Amy AY2862
FDA UDI
Class IIUnknown
Urea UR3825
FDA UDI
Class IIActive
Immunoassay Premium Plus - Level 2 (ia Premium Plus 2) IA3110
FDA UDI
Class IActive
Butyryl Cholinesterase (che) CE190
FDA UDI
Class IActive
Liquid Crp Control - Level 2 (crp Control 2) CP2480
FDA UDI
Class IActive
Rabs RP3857
FDA UDI
Class IActive
Urea UR221
FDA UDI
Class IIActive
Triglycerides (trigs) TR8147
FDA UDI
Class IActive
G-6-Pdh Deficient Control (g-6-Pdh Control D) PD2617
FDA UDI
Class IActive
Lp (a) LP2878
FDA UDI
Class IIUnknown
Liquid Frozen Lipid Control - Level 3 (liq Lpd Control 3) LE10176
FDA UDI
Class IActive
Methamp DA4007
FDA UDI
Class IIActive
Alpha-1-Acid-Glycoprotein (agt) AG2472
FDA UDI
Class IUnknown

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