FDA Registration
Active
🇬🇧 United Kingdom
ConcizuTrace Sample Collection Kit
Reg #: 3014607865
·
FEI: 3014607865
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
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 |
|---|---|---|---|---|---|
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2023-07-31 |
Proprietary Names
ConcizuTrace Sample Collection Kit
EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA U60)
ESSENTIAL PACKAGE SAMPLE COLLECTION KIT (USA)
EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility