Data / Medical devices / System, Test, Automated, Antimicrobial Susceptibility, Short Incubation / United States
FDA-registered makers of System, Test, Automated, Antimicrobial Susceptibility, Short Incubation in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON). 6 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
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- Device
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Product code
- LON
- Country
- United States
Makers of System, Test, Automated, Antimicrobial Susceptibility, Short Incubation in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biomerieux, Inc. | Hazelwood, MO, United States | Manufacturer, Manufacturer for export, Specification developer | 111 | October 1, 2026 | 0 | 16 | 1 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 109 | August 8, 2025 | 0 | 15 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Cockeysville, MD, United States | Manufacturer | 2 | April 29, 2005 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson and Company | Mebane, NC, United States | Manufacturer | 2 | April 29, 2005 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | West Sacramento, CA, United States | Contract manufacturer, Manufacturer, Manufacturer for export | 1 | August 30, 2020 | 0 | 4 | 2 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 1 | November 26, 2003 | 0 | 0 | 0 | api.fda.gov |
| Affinity Biosensors | Santa Barbara, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hach Company | Ames, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hardy Diagnostics | Orcutt, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vorzeigen | Connersville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.