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 5 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sp Control 1 | PS2682 | FDA UDI | Class I | Active |
| Bil | BR412 | FDA UDI | Class II | Active |
| Gluc-Hk | GL1611 | FDA UDI | Class II | Active |
| Cysc Cal | CYS2699 | FDA UDI | Class II | Active |
| Anti-Streptolysin O Standard (aso Std) | LO2306 | FDA UDI | Class II | Active |
| Amy | AY9707 | FDA UDI | Class II | Active |
| Ldh P-L | LD401 | FDA UDI | Class II | Active |
| Rf | RF3836 | FDA UDI | Class II | Active |
| Crp | CP2852 | FDA UDI | Class II | Active |
| T Bil | BR2802 | FDA UDI | Class II | Active |
| Nh3 | AM3979 | FDA UDI | Class I | Active |
| Crp | CP7949 | FDA UDI | Class II | Unknown |
| Ammonia (nh3) | AM1054 | FDA UDI | Class I | Active |
| C3 | CM3845 | FDA UDI | Class II | Active |
| Liquid Assayed Chemistry Control Premium Plus - Level 3 (liq Chem Asy Premium Pl | LAE4215 | FDA UDI | Class I | Active |
| Ransel Control | SC692 | FDA UDI | Class I | Active |
| Liquid Cardiac Control 3 | CQ10536 | FDA UDI | Class I | Active |
| Triglycerides (trigs) | TR210 | FDA UDI | N/A | Active |
| Specific Protein Control - Level 1 (sp Control 1) | PS10221 | FDA UDI | Class I | Active |
| Sabs | SP8399 | FDA UDI | Class I | Active |
| I.s.e. K | D200-0015 | FDA UDI | Class II | Active |
| G-6-Pdh Normal Control (g-6-Pdh Control N) | PD2618 | FDA UDI | Class I | Active |
| Lco2-2 | CD8357 | FDA UDI | Class II | Active |
| HbA1c II CALIBRATOR SET (HbA1c II CAL) | HA8124 | FDA UDI | Class II | Active |
| Triglycerides (trigs) | TR8332 | FDA UDI | Class I | Active |
| Urinalysis Control - Level 1 (urnal Control 1) | UC5033 | FDA UDI | Class I | Active |
| Crp Cal | CP2479 | FDA UDI | Class II | Active |
| Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3) | LAE10627 | FDA UDI | Class I | Active |
| Sp Control 2 | PS2683 | FDA UDI | Class I | Active |
| Fe | SI3821 | FDA UDI | Class I | Active |
| HbA1C | HA8321 | FDA UDI | Class II | Active |
| Ck Nac | CK522 | FDA UDI | Class II | Active |
| Eddp Cal | DA2702 | FDA UDI | Class II | Active |
| Essential Package Sample Collection Kit (usa) | SCK10684 | FDA UDI | Class II | Active |
| Mdma Cal | DA2701 | FDA UDI | Class II | Active |
| Ammonia (nh3) | AM1015 | FDA UDI | Class I | Active |
| P Amy | AY7934 | FDA UDI | Class II | Active |
| Acp | AC1011 | FDA UDI | Class II | Active |
| T Bil | BR9766 | FDA UDI | Class II | Active |
| Total Protein (tp) | TP3869 | FDA UDI | Class II | Active |
| IgA | IA3832 | FDA UDI | Class II | Active |
| LD opt. (LDH P-L) | LD8051 | FDA UDI | Class II | Active |
| IgE CAL SET | IE2492 | FDA UDI | Class II | Active |
| Total Iron-Binding Capacity 2 (tibc_2) | TI8065 | FDA UDI | Class I | Active |
| Total Protein (up) | UP1570 | FDA UDI | Class I | Active |
| D Bil | BR9765 | FDA UDI | Class II | Active |
| Ldh P-L | LD3818 | FDA UDI | Class II | Active |
| Ferr | FN3452 | FDA UDI | Class II | Active |
| Cystatin C Control - Level 2 (cysc Control 2) | CYS10446 | FDA UDI | Class I | Active |
| Alanine Aminotransferase (alt) | AL1268 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.