FDA Registration
Active
🇬🇧 United Kingdom
Atellica CH Liquid Specific Protein Calibrators (LSP CAL)
Reg #: 3014607865
·
FEI: 3014607865
·
Expires 2025
Products
1
Proprietary Names
7
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 |
|---|---|---|---|---|---|
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2018-07-11 |
Proprietary Names
Atellica CH Liquid Specific Protein Calibrators (LSP CAL)
Atellica CH Special Chemistry Calibrator (SPCL CHEM CAL)
Atellica CH Apolipoprotein A-1 & B Calibrator (APO A1 & B CAL)
Consolidated Chemistry Calibrator (ALINITY; LN 04V6201)
Consolidated Chemistry Calibrator (ARCHITECT; LN 04V1501)
Lipid Multiconstituent Calibrator Kit
Lipid Multiconstituent Calibrator
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)