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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 11 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Immunoassay Speciality I - Level 2 (ia Speciality I Lev 2) | IAS3114 | FDA UDI | Class I | Active |
| Rf | RF7980 | FDA UDI | Class II | Active |
| Phb | TD3408 | FDA UDI | Class II | Active |
| Randox Complement C3 | K000469 | FDA 510(k) | Class II | Active |
| Randox C-Reactive Protein Calibrator | K022682 | FDA 510(k) | Class II | Active |
| Randox Benzodiazepine Class Assay | K050179 | FDA 510(k) | Class II | Active |
| Urea Kit | K923506 | FDA 510(k) | Class II | Active |
| Randox Ige | K010855 | FDA 510(k) | Class II | Active |
| Randox Albumin | K000483 | FDA 510(k) | Class II | Active |
| Uric Acid Enzymatic Colorimeric Kit | K923503 | FDA 510(k) | Class I | Active |
| Randox Digoxin | K011302 | FDA 510(k) | Class II | Active |
| Randox Human Asssayed Drug Control | K012319 | FDA 510(k) | Class I | Active |
| Randox Ecstasy (mdma) Assay | K092275 | FDA 510(k) | Class II | Active |
| Sodium Test Kit And Eletrolyte Cal 1 And 2 | K043268 | FDA 510(k) | Class II | Active |
| Iga Immunoturbidimetric & Calibrator | K955794 | FDA 510(k) | Class II | Active |
| Pancreatic Amylase, Ethylidene Blocked-Pnpg7 Enzyme Colorimetric Test | K971825 | FDA 510(k) | Class II | Active |
| Glucose (hexokinase) Kit | K953210 | FDA 510(k) | Class II | Active |
| Amylase (ethylidene Pngpg7) Kit | K953211 | FDA 510(k) | Class II | Active |
| Randox Bariturates Assay | K092268 | FDA 510(k) | Class II | Active |
| C-Reactive Protein Latex Kit | K954447 | FDA 510(k) | Class II | Active |
| Cholesterol Enzymatic Endpoint | K923504 | FDA 510(k) | Class I | Active |
| Randox Methamphetamine Assay | K092266 | FDA 510(k) | Class II | Active |
| Randox Ferritin | K000662 | FDA 510(k) | Class II | Active |
| Randox Creatinine | K973993 | FDA 510(k) | Class II | Active |
| Randox Phenytoin | K011393 | FDA 510(k) | Class II | Active |
| Randox Phencyclidine Assay | K043071 | FDA 510(k) | U | Active |
| Rheumatoid Factor Latex-Enhanced Immunoturbidimetric Test Kit | K972220 | FDA 510(k) | Class II | Active |
| Igm Immunotrubidimetric & Calibrator | K955797 | FDA 510(k) | Class II | Active |
| Randox Myoglobin | K010700 | FDA 510(k) | Class II | Active |
| Direct Hdl-Cholestrol Liquid | K982341 | FDA 510(k) | Class I | Active |
| Randox Amikacin | K033884 | FDA 510(k) | Class II | Active |
| Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls | K023763 | FDA 510(k) | Class II | Active |
| Alkaline Phosphatase Kit | K923507 | FDA 510(k) | Class II | Active |
| Boehringer Mannheim Direct Hdl-Cholesterol | K970735 | FDA 510(k) | Class I | Active |
| Igg Immunoturbidimetric & Calibrator | K955798 | FDA 510(k) | Class II | Active |
| Randox Digoxin Assay | K102346 | FDA 510(k) | Class II | Active |
| Randox Valproic Acid | K011649 | FDA 510(k) | Class II | Active |
| Randox Uric Acid | K033278 | FDA 510(k) | Class I | Active |
| Rx Daytona Plus Chemistry Analyzer; Rx Daytona Plus Aspartate Aminotransferase (ast) Reagent | K131554 | FDA 510(k) | Class I | Active |
| Alt (gpt) - Alanine Aminotransferase | K923510 | FDA 510(k) | Class I | Active |
| Randox Immunoassay Speciality Control (ii), Level 1, Level 2 And Level 3 | K121603 | FDA 510(k) | Class I | Active |
| Randox Liquid Urine Control Levels 2 And 3 | K110904 | FDA 510(k) | Class I | Active |
| Randox Cystatin C Control Level 2 Randox Cystatin C Control Level 3 | K121588 | FDA 510(k) | Class I | Active |
| Randox Cocaine Metabolite | K113751 | FDA 510(k) | Class II | Active |
| Randox Liquid Ck-Mb, Randox Ck-Mb Calibrator | K123977 | FDA 510(k) | Class II | Active |
| Ast (got) - Aspartate Aminotransferase | K923505 | FDA 510(k) | Class II | Active |
| Randox Magnesium | K974606 | FDA 510(k) | Class I | Active |
| Randox Methadone Assay | K092272 | FDA 510(k) | Class II | Active |
| Randox Microalbumin Control Level 1 And Control Level 2 (liquid) | K121746 | FDA 510(k) | Class I | Active |
| Lactate Dehydrogenase (ld) | K970684 | FDA 510(k) | Class II | Active |
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