FDA Registration
Active
🇬🇧 United Kingdom
R2476096 ProSpecT Campylobacter Microplate Assay 96 Tests
Reg #: 8010096
·
FEI: 3006224287
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- OXOID, LTD.
- Registration Number
- 8010096
- FEI Number
- 3006224287
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- WADE RD.
- City
- BASINGSTOKE, HAMPSHIRE
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K982315
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
US Agent
- Business Name
- Remel, Inc
- Contact Name
- Alycia Jayroe
- Address
- 12076 Santa Fe Trail
- City
- Lenexa
- State
- KS
- ZIP
- 66215
- Country
- US
- [email protected]
- Phone
- 913 9540078
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Campylobacter Spp. | LQP | Class 1 | Microbiology | No | 2005-10-12 |
Proprietary Names
R2476096 ProSpecT Campylobacter Microplate Assay 96 Tests
ProSpecT Campylobacter Microplate Assay
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device