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US
Last updated May 24, 2026
What THERADIAG SA makes
Theradiag SA manufactures in vitro diagnostics (IVDs) for detecting and confirming autoantibody markers, including phospholipid antibodies, coeliac disease-associated antibodies, extractable nuclear antigen (anti-ENA) antibodies, mitochondrial antibody M2 (anti-Mi2), thyroid antibodies, and vasculitis-associated antibodies. Their products include controls, kits, and multiplex assays designed for laboratory testing.
The company’s portfolio is regulated under the FDA’s Unique Device Identification (UDI) system in the United States. Devices are classified as Class II medical devices, requiring performance standards and pre-market submissions where applicable. The manufacturer is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- theradiag.com
- —
- —
- [email protected]
- Phone
- 0164621012
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 391123478
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Immuno-Trol | CELIAC IgA | FDA UDI | N/A | Active |
| Immuno-Trol | RHEUMA | FDA UDI | N/A | Active |
| Fidis | Vasculitis | FDA UDI | N/A | Active |
| Immuno-Trol | GASTRITIS | FDA UDI | N/A | Active |
| Immuno-Trol | CONNECTIVE 2 | FDA UDI | N/A | Active |
| Immuno-Trol | APS IgM | FDA UDI | N/A | Active |
| Immuno-Trol | CONNECTIVE 1 | FDA UDI | N/A | Active |
| Immuno-Trol | THYRO | FDA UDI | N/A | Active |
| Fidis | Connective 10 | FDA UDI | N/A | Active |
| Immuno-Trol | CELIAC IgG | FDA UDI | N/A | Active |
| Immuno-Trol | VASCULITIS | FDA UDI | N/A | Active |
| Immuno-Trol | CYTO | FDA UDI | N/A | Active |
| Immuno-Trol | APS IgG | FDA UDI | N/A | Active |
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