FDA Registration
Active
🇬🇧 United Kingdom
PK7400 TP HA REAGENT
Reg #: 3011801330
·
FEI: 3011801330
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NEWMARKET BIOMEDICAL LTD
- Registration Number
- 3011801330
- FEI Number
- 3011801330
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 1, Lanwades Business Park
- City
- Kentford Suffolk
- Country
- GB
Regulatory Submissions
- 510(k) Number
- BK180301
Owner / Operator
- Firm Name
- Newmarket Biomedical Ltd
- Operator Number
- 10061491
- Address
- Unit 1, Lanwades Business Park
- City
- Kentford
- State
- Suffolk
- Postal Code
- CB8 7PN
- Country
- GB
- Correspondent
- Mark R Bates
US Agent
- Business Name
- New World Regulatory Solutions Inc
- Contact Name
- Maureen Garner
- Address
- 11700 W. Charleston Blvd, Suite 170-390
- City
- Las Vegas
- State
- NV
- ZIP
- 89135
- Country
- US
- [email protected]
- Phone
- 732 7797422
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Donor, Syphilis, Antigens, Treponemal | MYR | Class 2 | Microbiology | No | 2019-10-23 |
Proprietary Names
PK7400 TP HA REAGENT
PK7400 TP HA CONTROLS
Establishment Types
Manufacture Medical Device