FDA Registration
Active
🇮🇪 Ireland
Evidence MultiSTAT
Reg #: 3009473156
·
FEI: 3009473156
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Randox Teoranta
- Registration Number
- 3009473156
- FEI Number
- 3009473156
- Status
- Active
- Expiry Year
- 2025
- 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
- Sammy Alnajm
- 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 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | 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 |
Proprietary Names
Evidence MultiSTAT
Evidence MultiSTAT DOA Urine Multiplex
Establishment Types
Manufacture Medical Device