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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 9 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Liquid Urine Control - Level 2 (liq Urn Control 2) | UC5074 | FDA UDI | Class I | Active |
| Liquid Frozen Lipid Control - Level 2 (liq Lpd Control 2) | LE10175 | FDA UDI | Class I | Active |
| Tri-Level Cardiac Control (crd Control 1, 2, 3) | CQ3100 | FDA UDI | Class I | Active |
| Uibc | SI250 | FDA UDI | Class I | Active |
| Acid Phosphatase (acp) | AC8001 | FDA UDI | Class II | Active |
| IgG | IG3896 | FDA UDI | Class II | Active |
| Rf | RF7981 | FDA UDI | Class II | Unknown |
| Liquid Crp Control - Level 3 (crp Control 3) | CP2481 | FDA UDI | Class I | Active |
| Butyryl Cholinesterase (che) | CE7944 | FDA UDI | Class I | Active |
| Amy | AY7931 | FDA UDI | Class II | Active |
| PREALBUMIN (PreALB) | PA3843 | FDA UDI | Class I | Active |
| IgG | IG7158 | FDA UDI | Class II | Active |
| Liquid Chemistry Premium Plus - Level 3 (liq Chem Premium Plus 3) | LUE5095 | FDA UDI | Class I | Active |
| Bovine Precision Multi Sera - Level 3 (bov Prec Control 3) | SE1086 | FDA UDI | Class I | Active |
| Fe | SI7967 | FDA UDI | Class I | Active |
| Calcium (Ca) | CA2390 | FDA UDI | Class II | Active |
| Extended Package Sample Collection Kit (usa U60) | SCK10689 | FDA UDI | Class II | Active |
| Ck Nac | CK113 | FDA UDI | Class II | Unknown |
| Cystatin C Control - Level 3 (cysc Control 3) | CYS5020 | FDA UDI | Class I | Active |
| Benz Control 1 | DA3130 | FDA UDI | Class I | Active |
| APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman Coulter AU Systems) | LV10363 | FDA UDI | Class I | Active |
| I.s.e. Cl | D400-0013 | FDA UDI | Class II | Active |
| Liquid Ranbut (rbt) | RB4067 | FDA UDI | Class I | Active |
| frCRP | CP3849 | FDA UDI | Class II | Active |
| Uric Acid (ua) | UA7972 | FDA UDI | Class I | Active |
| Evidence MultiSTAT DOA Urine MultiPlex | EV4393 | FDA UDI | Class II | Active |
| Apo B | LP3839 | FDA UDI | Class I | Active |
| Human Assayed Multi-Sera/Assayed Chemistry Premium Plus - Level 2 & 3 (hum Asy | HS2611 | FDA UDI | Class I | Active |
| Apolipoprotein A-Ii (apo A-Ii) | LP3867 | FDA UDI | Class I | Active |
| Alp | AP313 | FDA UDI | Class II | Active |
| Amy | AY1582 | FDA UDI | Class II | Unknown |
| Assayed Bovine Multi Sera - Level 3 (bov Asy Control 3) | AE1032 | FDA UDI | Class I | Active |
| Haematology Control - Level 3 (haem Cntl - Level 3) | HM10192 | FDA UDI | Class II | Active |
| Gluc-Hk | GL7954 | FDA UDI | Class II | Active |
| Amy | AY7932 | FDA UDI | Class II | Active |
| P Amy | AY3855 | FDA UDI | Class II | Active |
| Cholesterol (chol) | CH8310 | FDA UDI | Class I | Active |
| Fruc Control 3 | FR2996 | FDA UDI | Class I | Active |
| IgM | IM7977 | FDA UDI | Class II | Active |
| Rf | RF2716 | FDA UDI | Class II | Active |
| Gluc-Pap | GL1021 | FDA UDI | Class II | Active |
| Ast | AS7905 | FDA UDI | Class II | Unknown |
| Ck-Mb | CK4043 | FDA UDI | Class II | Active |
| IRON (Fe) | SI8330 | FDA UDI | Class I | Active |
| Myo Cal Set | MY2456 | FDA UDI | Class II | Active |
| Total-Iron Binding Capacity (tibc) | TI1010 | FDA UDI | Class I | Active |
| MAGNESIUM (Mg) | MG8326 | FDA UDI | Class I | Active |
| Cholesterol (chol) | CH200 | FDA UDI | N/A | Active |
| Uric Acid (ua) | UA8333 | FDA UDI | Class I | Active |
| Ck-Mb | CK1296 | FDA UDI | Class II | Active |
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