EUDAMED device
Hp Detect™ Stool Antigen ELISA
EUDAMED device 00083059070835 · Biomerica, Inc.
Key facts
| Primary DI | 00083059070835 |
|---|---|
| Trade name | Hp Detect™ Stool Antigen ELISA |
| Device name | HP Detect Stool Antigen ELISA |
| Reference or catalog number | 7083 |
| Model | 7083 |
| Manufacturer | Biomerica, Inc. |
| Manufacturer SRN | US-MF-000015772 |
| Risk class | IVD General |
| EMDN code | W0105010401 |
| EMDN description | H. PYLORI ANTIGEN DETECTION |
| Legislation | ivdd |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jan 13, 2026 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: