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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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- US
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Catalogue (597)
Page 8 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Co2 | CD129 | FDA UDI | Class II | Active |
| Co2 | CD116 | FDA UDI | Class II | Unknown |
| Rabs | RP8398 | FDA UDI | Class I | Active |
| Ast | AS2800 | FDA UDI | Class II | Active |
| Bovine Precision Multi Sera - Level 2 (bov Prec Control 2) | SN1085 | FDA UDI | Class I | Active |
| Cystatin C Calibrator (cysc Cal) | CYS10445 | FDA UDI | Class II | Active |
| Alanine Aminotransferase (alt) | AL8006 | FDA UDI | Class I | Active |
| Liquid Cardiac Control 1 | CQ10534 | FDA UDI | Class I | Active |
| MICROALBUMIN (mALB) | MA8056 | FDA UDI | Class II | Active |
| Alanine Aminotransferase (alt) | AL7930 | FDA UDI | Class I | Active |
| Liquid Assayed Chemistry Control Premium – Level 2 (liq Chem Asy Premium 2) | LAN4216 | FDA UDI | Class I | Active |
| Anti-Streptolysin-O 2 (aso 2) | LO3999 | FDA UDI | Class I | Active |
| T Bil | BR8307 | FDA UDI | Class II | Active |
| Doa Control 1 | DA3121 | FDA UDI | Class I | Active |
| CALCIUM (Ca) | CA8309 | FDA UDI | Class II | Active |
| Apo A-I | LP2866 | FDA UDI | Class I | Unknown |
| Gluc-Hk | GL8319 | FDA UDI | Class II | Active |
| Ferr | FN3453 | FDA UDI | Class II | Active |
| Abaxis Chemistry Control Level 2 | 1100-9132E | FDA UDI | Class I | Active |
| Doa | EV3542 | FDA UDI | Class II | Active |
| Dg | TD3410 | FDA UDI | Class II | Active |
| Fe | SI2818 | FDA UDI | Class I | Active |
| LD opt. (LDH L-P) | LD8052 | FDA UDI | Class II | Active |
| Coagulation Control - Level 1 (coag Control 1) | CG5021 | FDA UDI | Class I | Active |
| Apo A-I | LP2989 | FDA UDI | Class I | Active |
| Ast | AS1204 | FDA UDI | Class II | Active |
| Anti-Streptolysin-O 2 (aso 2) | LO3998 | FDA UDI | Class I | Active |
| Crp | CP1423 | FDA UDI | Class II | Active |
| Alanine Aminotransferase (alt) | AL2360 | FDA UDI | Class I | Active |
| Lipase (lps) | LI7979 | FDA UDI | Class I | Active |
| Apo A-I | LP2116 | FDA UDI | Class I | Active |
| Urea | UR8334 | FDA UDI | Class II | Active |
| Glycerol (gly) | GY105 | FDA UDI | Class I | Active |
| I.s.e. Na | D200-0014 | FDA UDI | Class II | Active |
| IgG | IG2448 | FDA UDI | Class II | Active |
| Lipase (lps) | LI3837 | FDA UDI | Class I | Active |
| Total Protein 2 (tp 2) | TP8336 | FDA UDI | Class II | Active |
| Cal B | RX3949 | FDA UDI | Class II | Active |
| Immunoassay Speciality Ii - Level 2 (ia Speciality Ii Lev 2) | IAS3118 | FDA UDI | Class I | Active |
| Ast | AS3804 | FDA UDI | Class II | Active |
| Lipase (lps) | LI8361 | FDA UDI | Class I | Active |
| Cal A | RX4000 | FDA UDI | Class II | Active |
| Ck Nac | CK110 | FDA UDI | Class II | Active |
| Doa Cal | EV3550 | FDA UDI | Class II | Active |
| Adiponectin Calibrator (adpn Cal) | AO2800 | FDA UDI | Class II | Active |
| Glycerol Control (gly Control) | GY1369 | FDA UDI | Class I | Active |
| Liquid Assayed Chemistry Control Premium Plus - Level 1 (liq Chem Asy Premium Pl | LAL4213 | FDA UDI | Class I | Active |
| HAEMOGLOBIN A1c (HbA1c) | HA3450 | FDA UDI | Class II | Active |
| frCRP | CP3847 | FDA UDI | Class II | Active |
| Hcy | HY4036 | FDA UDI | Class II | Active |
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