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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 4 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Triglycerides (trigs) | TR1697 | FDA UDI | N/A | Active |
| Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) | LAN10626 | FDA UDI | Class I | Active |
| Blood Gas Control - Level 3 (bg Control 3) | BG5003 | FDA UDI | Class I | Active |
| Immunoassay Premium - Level 1 (ia Premium 1) | IA2638 | FDA UDI | Class I | Active |
| Assayed Urine Control - Level 3 (urn Asy Control 3) | AU2353 | FDA UDI | Class I | Active |
| Crea | CR524 | FDA UDI | Class II | Active |
| Ca | CA7941 | FDA UDI | Class II | Active |
| Gluc-Pap | GL2614 | FDA UDI | Class II | Active |
| Lp (a) | LP3403 | FDA UDI | Class II | Active |
| HIGH SENSITIVITY C-REACTIVE PROTEIN LINEARITY VERIFIERS (For Roche Series) | LV10335 | FDA UDI | Class I | Active |
| Immunoassay Speciality I - Level 3 (ia Speciality I Lev 3) | IAS3115 | FDA UDI | Class I | Active |
| Aspartate Aminotransferase (ast) | AS147 | FDA UDI | Class II | Active |
| Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) | LAL10625 | FDA UDI | Class I | Active |
| Benz Control 2 | DA3131 | FDA UDI | Class I | Active |
| Human Assayed Multi-Sera/Assayed Chemistry Premium Plus - Level 3 (hum Asy Contr | HE1532 | FDA UDI | Class I | Active |
| hsCRP CAL | CP2478 | FDA UDI | Class II | Active |
| Ast | AS7938 | FDA UDI | Class II | Active |
| Maternal Control - Level 1 (maternal Control 1) | MSS5024 | FDA UDI | Class I | Active |
| Triglycerides (trigs) | TR9780 | FDA UDI | Class I | Active |
| Maternal Control - Level 3 (maternal Control 3) | MSS5026 | FDA UDI | Class I | Active |
| Barb | DA4008 | FDA UDI | Class II | Active |
| Apo A-I | LP3838 | FDA UDI | Class I | Active |
| Glutathione Reductase Control Serum (glut Red Control) | GR2608 | FDA UDI | Class I | Active |
| hsCRP | CP3885 | FDA UDI | Class II | Active |
| RX daytona | RX3900 | FDA UDI | Class I | Active |
| Alp | AP311 | FDA UDI | Class II | Active |
| Gluc-Pap | GL7952 | FDA UDI | Class II | Active |
| Gamma-Glutamyltranserase (ggt) | GT3874 | FDA UDI | Class I | Active |
| IgA | IA3895 | FDA UDI | Class II | Unknown |
| Non-Esterified Fatty Acids (NEFA) | FA115 | FDA UDI | Class I | Active |
| Chol | CH3810 | FDA UDI | Class I | Active |
| HbA1C CAL | HA3444 | FDA UDI | Class II | Active |
| Ca | CA3871 | FDA UDI | Class II | Active |
| Leucine Arylamidase (lap) | LA561 | FDA UDI | Class I | Active |
| Crp | CP2572 | FDA UDI | Class II | Unknown |
| Alanine Aminotransferase (alt) | AL146 | FDA UDI | Class I | Active |
| Ace | ACE4023 | FDA UDI | Class II | Active |
| Benz Cal | DA3129 | FDA UDI | Class II | Active |
| Cystatin C Control - Level 2 (cysc Control 2) | CYS5019 | FDA UDI | Class I | Active |
| Ast | AS1267 | FDA UDI | Class II | Active |
| Urea | UR456 | FDA UDI | Class II | Active |
| Urea | UR220 | FDA UDI | Class II | Active |
| Total-Iron Binding Capacity (tibc) | TI8331 | FDA UDI | Class I | Active |
| Lp (a) | LP2757 | FDA UDI | Class II | Active |
| Gamma-Glutamyltranserase (ggt) | GT8146 | FDA UDI | Class I | Active |
| Tf | TF7197 | FDA UDI | Class II | Active |
| LIPID LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Lipid LinVer - BC) | LV10364 | FDA UDI | Class I | Active |
| Pht | TD3409 | FDA UDI | Class II | Active |
| Ck Nac | CK3812 | FDA UDI | Class II | Active |
| Tf | TF3831 | FDA UDI | Class II | Active |
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