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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 10 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Doa Control 2 | DA3122 | FDA UDI | Class I | Active |
| Ck Nac | CK335 | FDA UDI | Class II | Active |
| Immunoassay Premium - Tri-Level (ia Premium 1, 2 And 3) | IA2633 | FDA UDI | Class I | Active |
| LD opt. (LDH L-P) | LD8323 | FDA UDI | N/A | Active |
| Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) | LAN10566 | FDA UDI | Class I | Active |
| Maternal Control - Level 2 (maternal Control 2) | MSS5025 | FDA UDI | Class I | Active |
| Liquid Glycated Haemoglobin (HbA1c) Control set (LIQ HbA1c CONTROL) | HA10155 | FDA UDI | Class I | Active |
| Uric Acid (ua) | UA3824 | FDA UDI | N/A | Active |
| Triglycerides (trigs) | TR8067 | FDA UDI | Class I | Active |
| Rf | RF2881 | FDA UDI | Class II | Active |
| Alb | AB362 | FDA UDI | Class II | Active |
| Blood Gas Control - Level 2 (bg Control 2) | BG5002 | FDA UDI | Class I | Active |
| Ferr | FN3888 | FDA UDI | Class II | Active |
| Apo B | LP2867 | FDA UDI | Class I | Active |
| Amh Control Level 2 (amh Control 2) | AMH10514 | FDA UDI | Class I | Active |
| CLINICAL CHEMISTRY LINEARITY VERIFIERS (For Roche Systems) | LV10390 | FDA UDI | Class I | Active |
| Ransel Calibrator (ransel Cal) | SC10154 | FDA UDI | Class II | Active |
| Crp Cal | CP2499 | FDA UDI | Class II | Active |
| Total Bilirubin 2 (t Bil 2) | BR8377 | FDA UDI | Class II | Active |
| Uric Acid (ua) | UA230 | FDA UDI | N/A | Active |
| Gluc-Hk | GL3816 | FDA UDI | Class II | Active |
| Amy | AY1580 | FDA UDI | Class II | Active |
| Extended Package Sample Collection Kit (usa) | SCK10685 | FDA UDI | Class II | Active |
| Adiponectin Control - Level 2 (adpn Control 2) | AO2801 | FDA UDI | Class I | Active |
| Inorganic Phosphorous (phos) | PH3872 | FDA UDI | Class I | Active |
| Liquid Urine Control - Level 3 (liq Urn Control 3) | UC5075 | FDA UDI | Class I | Active |
| D-3 Hydroxybutyrate (RANBUT) | RB1007 | FDA UDI | Class I | Active |
| Gluc-Pap | GL364 | FDA UDI | Class II | Active |
| Creatinine (crea) | CR510 | FDA UDI | Class II | Active |
| Amh Control Level 4 (amh Control 4) | AMH10516 | FDA UDI | Class I | Active |
| Crp Cal | CP2179 | FDA UDI | Class II | Active |
| Beta 2 Microglobulin Calibrator (b2m Cal) | BM1362 | FDA UDI | Class II | Active |
| Assayed Urine Control - Level 2 (urn Asy Control 2) | AU2352 | FDA UDI | Class I | Active |
| C-REACTIVE PROTEIN LINEARITY VERIFIERS (For Roche Series) (CPLV) | LV10334 | FDA UDI | Class I | Active |
| Eddp Control 1 | DA3123 | FDA UDI | Class I | Active |
| Apolipoprotein C-Iii (apo C-Iii) | LP3865 | FDA UDI | Class I | Active |
| Alb | AB3800 | FDA UDI | Class II | Active |
| B2Microglobulin (B2M) | BM8016 | FDA UDI | Class II | Active |
| I.s.e. K | D400-0012 | FDA UDI | Class II | Active |
| Sabs | SP3856 | FDA UDI | Class I | Active |
| Amy | AY3805 | FDA UDI | Class II | Active |
| Alb | AB3800 | FDA UDI | Class II | Active |
| Anti-Streptolysin O (ASO) | LO2715 | FDA UDI | Class I | Active |
| Cbz | TD3416 | FDA UDI | Class II | Active |
| THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems) | LV10355 | FDA UDI | Class I | Active |
| Gluc-Pap | GL3981 | FDA UDI | Class II | Active |
| Ck-Mb Control | CK1212 | FDA UDI | Class II | Active |
| Liquid Frozen Bilirubin Control - Level 2 (liq Bil Control 2) | BR10443 | FDA UDI | Class I | Active |
| HbA1C CONTROL | HA5072 | FDA UDI | Class I | Active |
| Fruc Cal | FR2993 | FDA UDI | Class II | Active |
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