Infectious diseasesBacteriology (infect. immunology/NAT)Clostridium difficile
C.difficile toxin a/b detection
EMDN code W0105011802
Manufacturers registered in Europe (EUDAMED) 24
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 9
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Cepheid Present in Europe in other categories | United States | Xpert C. difficile | K091109 (2009) |
| MARDX DIAGNOSTICS, INC. | United States | Trinity Biotech | registered |
| Meridian Bioscience, Inc. Present in Europe in other categories | United States | ImmunoCard Toxins A & B PREMIER Toxins A and B | K041003 (2004) |
| ACESO LABORATORIES INC. Present in Europe in other categories | United States | – | registered |
| BBI Solutions OEM Limited | United Kingdom | – | registered |
| EPITOPE DIAGNOSTICS, INC. | United States | – | registered |
| First Light Diagnostics, Inc. | United States | – | K193490 (2021) |
| MEDICAL CHEMICAL CORPORATION | United States | – | registered |
| Scantibodies Laboratory Inc. | United States | – | registered |
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.