FDA Registration
Active
🇬🇧 United Kingdom
CytoCell Microdeletion (LPU*)
Reg #: 9710378
·
FEI: 3002646096
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CYTOCELL LIMITED
- Registration Number
- 9710378
- FEI Number
- 3002646096
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Oxford Gene Technology, 418 Cambridge Science Park, Milton Road
- City
- CAMBRIDGE Cambridgeshire
- Country
- GB
Owner / Operator
- Firm Name
- Oxford Gene Technology (IP) Limited
- Operator Number
- 9026291
- Address
- Oxford Gene Technology (IP) Limited, Unit 5, 4A Technology Drive,
- City
- Kidlington
- State
- Oxfordshire
- Postal Code
- OX5 1GN
- Country
- GB
- Correspondent
- Steve Chatters
US Agent
- Business Name
- OXFORD GENE TECHNOLOGY, INC.
- Contact Name
- Mike Ornelas
- Address
- 520 White Plains Rd Ste 500
- City
- N Tarrytown
- State
- NY
- ZIP
- 10591
- Country
- US
- [email protected]
- Phone
- 732 2079524
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2001-06-14 |
Proprietary Names
CytoCell Microdeletion (LPU*)
CytoCell Enumeration (LPE*)
Analyte Specific Reagents with the following brand names:
myProbes (MPA*, MPD*, MPH*, MPP*)
CytoCell Haematology (LPH*)
CytoCell Telomere (LPT*)
CytoCell Pathology (LPS*, LPD*)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device