Data / Medical devices / Reagents, Clostridium Difficile Toxin / United States
FDA-registered makers of Reagents, Clostridium Difficile Toxin in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Reagents, Clostridium Difficile Toxin (product code LLH). 7 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Reagents, Clostridium Difficile Toxin
- Product code
- LLH
- Country
- United States
Makers of Reagents, Clostridium Difficile Toxin in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Techlab, Inc. | Radford, VA, United States | Manufacturer | 4 | March 26, 2009 | 0 | 0 | 0 | api.fda.gov |
| Techlab, Inc. | Blacksburg, VA, United States | Manufacturer | 4 | March 26, 2009 | 0 | 0 | 0 | api.fda.gov |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 2 | August 20, 2004 | 0 | 2 | 0 | api.fda.gov |
| Cepheid | Sunnyvale, CA, United States | Manufacturer | 1 | July 9, 2009 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer | 1 | July 9, 2009 | 0 | 0 | 0 | api.fda.gov |
| Medical Chemical Corporation | Torrance, CA, United States | Manufacturer, Repackager or relabeler | 1 | May 27, 2004 | 0 | 0 | 0 | api.fda.gov |
| Remel, Inc. | Lenexa, KS, United States | Manufacturer | 1 | November 15, 2004 | 0 | 1 | 0 | api.fda.gov |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quidel Corp. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scantibodies Laboratory Inc. | San Diego, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.