FDA Registration
Active
🇫🇷 France
TOXOPLASMA ICT IgG IgM
Reg #: 3004914332
·
FEI: 3004914332
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LDBIO DIAGNOSTICS
- Registration Number
- 3004914332
- FEI Number
- 3004914332
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 24 Avenue Joannes Masset, Batiment 5
- City
- Lyon Rhone
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K831930
Owner / Operator
- Firm Name
- Ldbio Diagnostics
- Operator Number
- 10087442
- Address
- 24 Avenue Joannes Masset, Batiment 5
- City
- Lyon
- State
- Rhone
- Postal Code
- 69009
- Country
- FR
- Correspondent
- Denis Limonne
US Agent
- Business Name
- SANOVA CARE, LLC
- Contact Name
- KAMAL EL BISSATI
- Address
- 4939 S.KING DRIVE U.2
- City
- Chicago
- State
- IL
- ZIP
- 60615
- Country
- US
- [email protected]
- Phone
- 860 9447934
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Direct Agglutination Test, Toxoplasma Gondii | LLA | Class 2 | Microbiology | No | 2023-02-28 |
Proprietary Names
TOXOPLASMA ICT IgG IgM
Establishment Types
Manufacture Medical Device