FDA Registration
Active
🇬🇧 United Kingdom
BIOCARDHSV-2
Reg #: 9617136
·
FEI: 3002806511
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIO-DIAGNOSTICS LTD.
- Registration Number
- 9617136
- FEI Number
- 3002806511
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- UPTON INDUSTRIAL ESTATE,, RECTORY ROAD, UPTON-UPON SEVERN
- City
- WORCESTERSHIRE
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K983886
Owner / Operator
- Firm Name
- BIO-DIAGNOSTICS LTD.
- Operator Number
- 9035474
- Address
- UPTON INDUSTRIAL ESTATE, RECTORY ROAD
- City
- UPTON-UPON SEVERN
- State
- Worcestershire
- Postal Code
- WR8 0LX
- Country
- GB
- Correspondent
- Jemma Bullock
US Agent
- Business Name
- Dawa Medical LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 NW 12th Street, Suite 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 305 5999373 ext. 262
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | LGC | Class 2 | Microbiology | No | 2004-04-23 |
Proprietary Names
BIOCARDHSV-2
Establishment Types
Manufacture Medical Device