Data / Medical devices / Antigen, C. Difficile
Antigen, C. Difficile (MCB): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Antigen, C. Difficile (product code MCB, Class 1, 21 CFR 866.2660). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on October 9, 2013, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MCB
- Device class
- 1
- Regulation
- 866.2660
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| France | 1 |
| Mexico | 1 |
| Italy | 1 |
Makers of Antigen, C. Difficile
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 2 | December 16, 2011 | 0 | 1 | 0 | api.fda.gov |
| Biomerieux SA | MARCY L ETOILE Rhone, France | Manufacturer | 1 | October 9, 2013 | 0 | 0 | 0 | api.fda.gov |
| Techlab, Inc. | Radford, VA, United States | Manufacturer | 1 | April 26, 2006 | 0 | 0 | 0 | api.fda.gov |
| Techlab, Inc. | Blacksburg, VA, United States | Manufacturer | 1 | April 26, 2006 | 0 | 0 | 0 | api.fda.gov |
| Biomerica De Mexico, S.A. De C.V. | MEXICALI Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diesse Diagnostica Senese S.P.A | MONTERIGGIONI Siena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 9, 2013. 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.