Data / Medical devices / France / Theradiag
Theradiag: FDA-registered device maker in MARNE LA VALLEE CEDEX 2 Seine-et-Marne, France, 2 510(k) clearances
Theradiag is registered with the FDA (registration 3003935253) in MARNE LA VALLEE CEDEX 2 Seine-et-Marne, France. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 13, 2006. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003935253
- Address
- 14 rue AMBROISE CROIZAT CS 90136 CROISSY BEAUBOURG, MARNE LA VALLEE CEDEX 2 Seine-et-Marne, France, 77435
- Owner or operator
- THERADIAG (9065218)
- Roles
- Manufacturer
- First device listed
- January 7, 2005
- Registered through
- 2026
- Brand names listed
- CARIS, FIDIS CONNECTIVE 10, FIDIS VASCULITIS, IMMUNO-TROL, THERALIS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anti-Dna Antibody, Antigen And Control | LSW | 2 | Manufacturer | accessdata.fda.gov |
| Anti-Ribosomal P Antibodies | MQA | 2 | Manufacturer | accessdata.fda.gov |
| Anti-Rnp Antibody, Antigen And Control | LKO | 2 | Manufacturer | accessdata.fda.gov |
| Anti-Sm Antibody, Antigen And Control | LKP | 2 | Manufacturer | accessdata.fda.gov |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | 2 | Manufacturer | accessdata.fda.gov |
| Antinuclear Antibody, Antigen, Control | LKJ | 2 | Manufacturer | accessdata.fda.gov |
| Device, Microtiter Diluting/Dispensing | JTC | 1 | Manufacturer | accessdata.fda.gov |
| Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | MVJ | 2 | Manufacturer | accessdata.fda.gov |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | 2 | Manufacturer | accessdata.fda.gov |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | 2 | Manufacturer | accessdata.fda.gov |
| Whole Human Serum, Antigen, Antiserum, Control | DGR | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 13, 2006 | K053653 | FIDIS CONNECTIVE 10, MODEL MX006 | LLL | Substantially Equivalent | Biomedical Diagnostics (Bmd) SA | accessdata.fda.gov |
| March 2, 2006 | K053012 | FIDIS VASCULITIS, MODEL MX007 | MOB | Substantially Equivalent | Biomedical Diagnostics (Bmd) SA | accessdata.fda.gov |
Compare with other makers
- All makers of Whole Human Serum, Antigen, Antiserum, Control
- All makers of Device, Microtiter Diluting/Dispensing
- All makers of Anti-Rnp Antibody, Antigen And Control
- All makers of Antinuclear Antibody, Antigen, Control
- All makers of Anti-Dna Antibody, Antigen And Control
- All makers of Extractable Antinuclear Antibody, Antigen And Control
Updated March 13, 2006. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.