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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 12 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Randox Ethanol Assay | K092273 | FDA 510(k) | Class II | Active |
| Total Co2 | K951221 | FDA 510(k) | Class II | Active |
| Randox Calcium (Ca) | K182042 | FDA 510(k) | Class II | Active |
| Ck-Nac Activated Kit | K923511 | FDA 510(k) | Class II | Active |
| Randox Calcium | K000375 | FDA 510(k) | Class II | Active |
| Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, And Benzodiazepine Control Level 2 | K132090 | FDA 510(k) | Class II | Active |
| Randox Csf Controls Levels 2 And 3 | K132156 | FDA 510(k) | Class I | Active |
| Apolipoprotein A-I Immunoturbidimetric Kit | K950383 | FDA 510(k) | Class I | Active |
| Randox Inorganic Phosphorous | K974605 | FDA 510(k) | Class I | Active |
| Triglycerides Gpo-Pap | K923508 | FDA 510(k) | Class I | Active |
| Randox Albumin | K984494 | FDA 510(k) | Class II | Active |
| Randox Theophylline | K011771 | FDA 510(k) | Class II | Active |
| Calibration Serum Level 1 & 2 | K955489 | FDA 510(k) | Class II | Active |
| Rheumatoid Factor Latex Slide Test Kit | K961169 | FDA 510(k) | Class II | Active |
| Randox Methadone Assay | K040570 | FDA 510(k) | Class II | Active |
| Randox C-Reactive Protein | K001009 | FDA 510(k) | Class II | Active |
| Total Protein (urine) | K951222 | FDA 510(k) | Class I | Active |
| Randox Complement C4 | K000468 | FDA 510(k) | Class II | Active |
| Randox RX Daytona Plus Magnesium (MG) | K162200 | FDA 510(k) | Class I | Active |
| Cannabinoid Assay And The Randox Cannabinoid Calibrator/ Control Set | K092269 | FDA 510(k) | Class II | Active |
| Randox Prealbumin | K000661 | FDA 510(k) | Class I | Active |
| Randox Cannabinoids Asssay | K041142 | FDA 510(k) | Class II | Active |
| Gamma-Gt | K923509 | FDA 510(k) | Class I | Active |
| Apolipoprotein B Immunoturbidiemetric Kit | K950382 | FDA 510(k) | Class I | Active |
| Randox Glucose (god/Pap) | K003346 | FDA 510(k) | Class II | Active |
| Randox Iron | K974604 | FDA 510(k) | Class I | Active |
| Randox Liquid Immunoassay Premium Controls, Level 1, Level2, Level 3 And Tri Level | K112337 | FDA 510(k) | Class I | Active |
| Randox Phenobarbital | K011303 | FDA 510(k) | Class II | Active |
| Randox Opiates Assay | K041144 | FDA 510(k) | Class II | Active |
| Liquid CO2-2 (LCO2-2) | K152085 | FDA 510(k) | Class II | Active |
| Randox Liquid Crp Controls | K040351 | FDA 510(k) | Class I | Active |
| Randox Benzodiazepine Assay | K092274 | FDA 510(k) | Class II | Active |
| Randox Metabolite (eddp) Assay | K092258 | FDA 510(k) | Class II | Active |
| Randox Amphetamine Class Assay | K040350 | FDA 510(k) | Class II | Active |
| Randox Digitoxin | K012112 | FDA 510(k) | Class II | Active |
| Potassium Test Kit And Electrolyte Cal 1 And 2 | K043267 | FDA 510(k) | Class II | Active |
| Ck-Mb (nac-Act) | K951223 | FDA 510(k) | Class II | Active |
| Randox Maternal Control, Levels 1, 2 And 3 | K113720 | FDA 510(k) | Class I | Active |
| Randox Barbiturate Assay | K041143 | FDA 510(k) | Class II | Active |
| ISE Electrodes | K230890 | FDA 510(k) | Class II | Active |
| Precision-Multi-Sera - Human - Normal And Elevated | K942458 | FDA 510(k) | Class I | Active |
| Randox Gentamicin | K012978 | FDA 510(k) | Class II | Active |
| Randox Haemoglobin A1c | K021897 | FDA 510(k) | Class II | Active |
| Randox Calcium | K974607 | FDA 510(k) | Class II | Active |
| Randox Therapeutic Drug Calibrator | K012318 | FDA 510(k) | Class II | Active |
| Randox Assayed Specific Protein Control | K972608 | FDA 510(k) | Class I | Active |
| Randox Carbamazepine | K011648 | FDA 510(k) | Class II | Active |
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