FDA Registration
Active
🇬🇧 United Kingdom
CytoCell 24 Square Template Slides (PCN 007)
Reg #: 9710378
·
FEI: 3002646096
·
Expires 2025
Products
1
Proprietary Names
15
Establishment Types
3
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 |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2012-01-05 |
Proprietary Names
CytoCell 24 Square Template Slides (PCN 007)
CytoCell Porcelain Wash Jars (PCN 009)
CytoCell Hybridisation Chamber (PCN 004)
CytoCell Rubber Solution Glue (PCA 005)
CytoCell Hybridisation Solution B (HB 500L, HB 1000L)
CytoCell DAPI Antifade Counterstain SS (DSS 500L)
CytoCell 20x SSC Buffer (PCA 003)
CytoCell Slide Surface Thermometer (PCN 002)
CytoCell DAPI Antifade Counterstain FS (DFS 500L, DFS 10ML)
CytoCell Hybridisation Solution I (HI 1000L)
CytoCell Mounting Medium (PCN 003)
CytoCell DAPI Antifade Counterstain ES (DES 500L, DES 1000L, DES 10ML)
CytoCell Tissue Pretreatment Kit (LPS 100)
CytoCell 8 Square Template Slides (PCN 008)
CytoCell
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198