FDA Registration
Active
🇫🇷 France
THERADIAG
Reg #: 3003935253
·
FEI: 3003935253
·
Expires 2026
Products
11
Proprietary Names
5
Establishment Types
1
Classifications
11
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Registration Details
- Registration Name
- THERADIAG
- Registration Number
- 3003935253
- FEI Number
- 3003935253
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14 rue AMBROISE CROIZAT, CS 90136 CROISSY BEAUBOURG
- City
- MARNE LA VALLEE CEDEX 2 Seine-et-Marne
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K053653
Owner / Operator
- Firm Name
- THERADIAG
- Operator Number
- 9065218
- Address
- 14 rue AMBROISE CROIZAT, CS 90136 CROISSY BEAUBOURG
- City
- MARNE LA VALLEE CEDEX 2
- State
- FR-NOTA
- Postal Code
- 77435
- Country
- FR
- Correspondent
- Evelyne - KOERTJE
US Agent
- Business Name
- Chembio Diagnostic Systems
- Contact Name
- Thomas Ippolito
- Address
- 3661 Horseblock Road
- City
- Medford
- State
- NY
- ZIP
- 11763
- Country
- US
- [email protected]
- Phone
- 631 9241135 ext. 122
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Whole Human Serum, Antigen, Antiserum, Control | DGR | Class 1 | Immunology | No | 2015-07-08 |
| Anti-Rnp Antibody, Antigen And Control | LKO | Class 2 | Immunology | No | 2005-01-07 |
| Anti-Dna Antibody, Antigen And Control | LSW | Class 2 | Immunology | No | 2005-01-07 |
| Antinuclear Antibody, Antigen, Control | LKJ | Class 2 | Immunology | No | 2005-01-07 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2005-01-07 |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2005-01-07 |
| Anti-Sm Antibody, Antigen And Control | LKP | Class 2 | Immunology | No | 2005-01-07 |
| Anti-Ribosomal P Antibodies | MQA | Class 2 | Immunology | No | 2005-01-07 |
| Device, Microtiter Diluting/Dispensing | JTC | Class 1 | Microbiology | No | 2005-03-02 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2006-03-13 |
| Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | MVJ | Class 2 | Immunology | No | 2006-03-13 |
Proprietary Names
IMMUNO-TROL
FIDIS CONNECTIVE 10
THERALIS
CARIS
FIDIS VASCULITIS
Establishment Types
Manufacture Medical Device