FDA Registration
Active
🇮🇪 Ireland
Randox Teoranta
Reg #: 3009473156
·
FEI: 3009473156
·
Expires 2026
Products
13
Proprietary Names
29
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- Randox Teoranta
- Registration Number
- 3009473156
- FEI Number
- 3009473156
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Meenmore
- City
- Dungloe Donegal
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K220451
Owner / Operator
- Firm Name
- RANDOX LABORATORIES, LTD.
- Operator Number
- 8020890
- Address
- 55 DIAMOND RD., --
- City
- CRUMLIN, CO.ANTRIM
- State
- GB-NOTA
- Postal Code
- BT29 4QY
- Country
- GB
- Correspondent
- Karena - Shaw
US Agent
- Business Name
- RANDOX LABORATORIES-US, LTD
- Contact Name
- John Naizer
- Address
- 515 Industrial Boulevard
- City
- Kearneysville
- State
- WV
- ZIP
- 25430
- Country
- US
- [email protected]
- Phone
- 304 7282890
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-09-11 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2024-09-11 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2024-09-11 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2024-09-11 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2024-09-11 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2023-09-20 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2023-09-20 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2023-09-20 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2004-03-16 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2014-01-27 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2007-08-01 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2007-08-01 |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2007-08-01 |
Proprietary Names
Evidence MultiSTAT DOA Urine Multiplex
Evidence MultiSTAT
CHOLRIDE ELECTRODE (I.S.E. Cl)
SODIUM ELECTRODE (I.S.E. Na)
POTASSIUM ELECTRODE (I.S.E. K)
RX IMOLA
ASPARTATE AMINOTRANSFERASE (AST)
RX daytona plus (with ISE)
H SOLUTION (H SOLN)
ETCHING (ETCH)
I.S.E. CLEANER (ISE CLN)
REFERENCE SOLUTION (REF SOLN)
I.S.E. DILUENT (ISE DIL)
RX daytona plus (without ISE)
SALINE DILUENT (NS)
ACID WASH SOLUTION (AWS)
L SOLUTION (L SOLN)
NORMAL SALINE (NS)
RX DAYTONA
CHLORIDE ISE
SODIUM ISE
POTASSIUM ISE
C1 Solution (C1 SOLN)
ALKALINE DETERGENT (Alkaline Detergent)
ACID WASH SOLUTION (WASH SOLN. 3)
ANTI-BACTERIAL DETERGENT (Detergent)
PRECISION CHECK SOLUTION (PREC)
ALKALINE WASH SOLUTION (WASH soln. 9)
RX monaco
Establishment Types
Manufacture Medical Device
Foreign Private Label Distributor