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Sign in to claim this brandWhat 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.
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Catalogue (597)
Page 2 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bovine Precision Multi Sera - Level 1 (bov Prec Control 1) | SL1084 | FDA UDI | N/A | Active |
| Drug Control - Level 2 (tdm Control 2) | HD1668 | FDA UDI | Class I | Active |
| L-Lactate (lac) | LC3980 | FDA UDI | Class I | Active |
| Abaxis Chemistry Control Level 1 | 1100-9131E | FDA UDI | Class I | Active |
| Benz | DA4009 | FDA UDI | Class II | Active |
| Sal | SAL4024 | FDA UDI | Class II | Active |
| IgM | IM3834 | FDA UDI | Class II | Active |
| Liquid Cardiac Control Level 3 (liquid Cardiac Control 3) | CQ10618 | FDA UDI | Class I | Active |
| Apo B | LP2117 | FDA UDI | Class I | Active |
| Liquid Cardiac Control Level 1 (liquid Cardiac Control 1) | CQ10616 | FDA UDI | Class I | Active |
| Drug Control - Level 3 (tdm Control 3) | HD1669 | FDA UDI | Class I | Active |
| Rf | RF1436 | FDA UDI | Class II | Active |
| Uric Acid (ua) | UA8069 | FDA UDI | Class I | Active |
| Cal 3 | CAL2351 | FDA UDI | Class II | Active |
| Liquid Assayed Chemistry Control Premium Plus - Level 2 (liq Chem Asy Premium Pl | LAN4214 | FDA UDI | Class I | Active |
| Crea | CR3814 | FDA UDI | Class II | Active |
| Fructosamine (fruc) | FR4030 | FDA UDI | Class I | Active |
| Ast | AS2359 | FDA UDI | Class II | Active |
| Urinalysis Control - Level 2 (urnal Control 2) | UC5034 | FDA UDI | Class I | Active |
| Crea | CR8316 | FDA UDI | Class II | Active |
| Alb | AB8301 | FDA UDI | Class II | Active |
| Mdma Control 2 | DA3126 | FDA UDI | Class I | Active |
| Total Protein (tp) | TP245 | FDA UDI | Class II | Active |
| Gent | TD3413 | FDA UDI | Class II | Active |
| APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R) | LV10357 | FDA UDI | Class I | Active |
| Urea | UR7976 | FDA UDI | Class II | Active |
| Thc Control 2 | DA3128 | FDA UDI | Class I | Active |
| Rf Cal | RF2301 | FDA UDI | Class II | Active |
| Ldh L-P | LD7963 | FDA UDI | Class II | Active |
| I.s.e. Ref | D200-0017 | FDA UDI | Class II | Active |
| EtOH | DA4015 | FDA UDI | Class II | Active |
| Mdma Control 1 | DA3125 | FDA UDI | Class I | Active |
| Tri-Level Cardiac Control (crd Control 1, 2, 3) | CQ3259 | FDA UDI | Class I | Active |
| Eddp | DA4013 | FDA UDI | Class II | Active |
| Coagulation Control - Level 2 (coag Control 2) | CG5022 | FDA UDI | Class I | Active |
| Immunoassay Premium - Level 3 (ia Premium 3) | IA2640 | FDA UDI | Class I | Active |
| Apolipoprotein E (apo E) | LP3864 | FDA UDI | Class I | Active |
| Urea | UR9729 | FDA UDI | Class II | Active |
| Alanine Aminotransferase (alt) | AL100 | FDA UDI | Class I | Active |
| Coagulation Control - Level 3 (coag Control 3) | CG5023 | FDA UDI | Class I | Active |
| Gluc-Pap | GL3815 | FDA UDI | Class II | Active |
| Ldl | CH3841 | FDA UDI | Class I | Active |
| Immunoassay Speciality I - Level 1 (ia Speciality I Lev 1) | IAS3113 | FDA UDI | Class I | Active |
| Myo | MY2127 | FDA UDI | Class II | Active |
| IgG | IG3833 | FDA UDI | Class II | Active |
| HIGH SENSITIVITY CRP CONTROL - LEVEL I (hsCRP CONTROL 1) | CP2476 | FDA UDI | Class I | Active |
| LIPOPROTEIN (a) (Lp (a)) | LP8324 | FDA UDI | Class I | Active |
| Crp | CP9742 | FDA UDI | Class II | Active |
| Crp | CP2714 | FDA UDI | Class II | Active |
| Direct Hdl-Cholesterol (hdl) | CH8033 | FDA UDI | Class I | Active |
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