Is this your brand? Sign in to claim ownership.
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.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (597)
Page 3 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| mALB | MA3828 | FDA UDI | Class II | Active |
| Ast | AS8306 | FDA UDI | Class II | Active |
| Direct Ldl-Cholesterol (ldl) | CH8032 | FDA UDI | Class I | Active |
| Cysc | CYS4004 | FDA UDI | Class II | Active |
| L Soln | D400-0018 | FDA UDI | Class I | Active |
| Ceruloplasmin (cpl) | CPL4017 | FDA UDI | Class II | Active |
| Eddp Control 2 | DA3124 | FDA UDI | Class I | Active |
| Immunoassay Premium Plus - Level 3 (ia Premium Plus 3) | IA3111 | FDA UDI | Class I | Active |
| Drug Control - Level 1 (tdm Control 1) | HD1667 | FDA UDI | Class I | Active |
| frCRP | CP3850 | FDA UDI | Class II | Unknown |
| Liquid Cardiac Control Level 2 (liquid Cardiac Control 2) | CQ10617 | FDA UDI | Class I | Active |
| HAEMOGLOBIN F AND A2 CONTROLS - LEVEL 1 AND 2 (Hb F & A2 CONTROL) | HA5083 | FDA UDI | Class II | Active |
| Apolipoprotein C-Ii (apo C-Ii) | LP3866 | FDA UDI | Class I | Active |
| B2Microglobulin (B2M) | BM3887 | FDA UDI | Class II | Active |
| Alanine Aminotransferase (alt) | AL1200 | FDA UDI | Class I | Active |
| mALB | MA2426 | FDA UDI | Class II | Active |
| HbA1C | HA3830 | FDA UDI | Class II | Active |
| Apolipoprotein A-I (apo A-I) | LP8007 | FDA UDI | Class I | Active |
| Aspartate Aminotransferase (ast) | AS8005 | FDA UDI | Class II | Active |
| LIPID LINEARITY VERIFIERS (For Roche Systems) (LLV-R) | LV10344 | FDA UDI | Class I | Active |
| Vpa | TD3414 | FDA UDI | Class II | Active |
| Crea | CR2804 | FDA UDI | Class II | Active |
| Cytokine High Sensitivity Controls (ctk Hs Control) | CY5005 | FDA UDI | Class I | Active |
| Ldh L-P | LD3842 | FDA UDI | Class II | Active |
| Amh Control Level 3 (amh Control 3) | AMH10515 | FDA UDI | Class I | Active |
| Serum Diluent (dil Sm) | MS5007 | FDA UDI | Class I | Active |
| I.s.e. Ref | D400-0010 | FDA UDI | Class II | Active |
| Haptoglobin (hp) | HP3886 | FDA UDI | Class II | Active |
| Ggt | GT3817 | FDA UDI | Class I | Active |
| Amy | AY2811 | FDA UDI | Class II | Active |
| Glutathione Reductase Calibration Serum (glut Red Cal) | GR2609 | FDA UDI | Class II | Active |
| Thc Cal | DA2700 | FDA UDI | Class II | Active |
| Urea | UR7975 | FDA UDI | Class II | Active |
| Liquid Chemistry Premium Plus - Level 2 (liq Chem Premium Plus 2) | LUN5094 | FDA UDI | Class I | Active |
| Specific Protein Control - Level 2 (sp Control 2) | PS10222 | FDA UDI | Class I | Active |
| Ast | AS3876 | FDA UDI | Class II | Active |
| Total Protein (up) | UP8113 | FDA UDI | Class I | Active |
| Urea | UR220 | FDA UDI | Class II | Active |
| Anti-Streptolysin-O 2 (aso 2) | LO8015 | FDA UDI | Class I | Active |
| D Bil | BR3807 | FDA UDI | Class II | Active |
| Lco2-2 | CD4006 | FDA UDI | Class II | Active |
| mALB | MA2423 | FDA UDI | Class II | Active |
| Urea | UR3873 | FDA UDI | Class II | Active |
| I.s.e. Na | D400-0011 | FDA UDI | Class II | Active |
| Tdm Cal | TD3417 | FDA UDI | Class II | Active |
| Li 2 | LM4005 | FDA UDI | Class II | Active |
| Ck Nac | CK3878 | FDA UDI | Class II | Active |
| Alanine Aminotransferase (alt) | AL1205 | FDA UDI | Class I | Active |
| LIPOPROTEIN (a) (Lp (a)) | LP8054 | FDA UDI | Class I | Active |
| Alp | AP2809 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.