FDA Registration
Active
🇬🇧 United Kingdom
THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems) (TDM LIN VER ROCHE)
Reg #: 3014607865
·
FEI: 3014607865
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- RANDOX LABORATORIES LIMITED
- Registration Number
- 3014607865
- FEI Number
- 3014607865
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 30 RANDALSTOWN ROAD
- City
- ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey
- Country
- GB
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 |
|---|---|---|---|---|---|
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2019-07-31 |
Proprietary Names
THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems) (TDM LIN VER ROCHE)
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device