Data / Medical devices / Discs, Strips And Reagents, Microorganism Differentiation / United States
FDA-registered makers of Discs, Strips And Reagents, Microorganism Differentiation in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Discs, Strips And Reagents, Microorganism Differentiation (product code JTO). 2 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Discs, Strips And Reagents, Microorganism Differentiation
- Product code
- JTO
- Country
- United States
Makers of Discs, Strips And Reagents, Microorganism Differentiation in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Remel, Inc. | Lenexa, KS, United States | Manufacturer, Specification developer | 47 | October 8, 1996 | 0 | 1 | 0 | api.fda.gov |
| Hardy Diagnostics | Orcutt, CA, United States | Manufacturer, Repackager or relabeler | 2 | June 17, 1996 | 0 | 1 | 0 | api.fda.gov |
| Anaerobe Systems | Morgan Hill, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Analytichem Usa, Inc. | Winslow, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson Caribe Ltd. | Cayey, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Esi Manufacturing, LLC | Gleason, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethos Biosciences, INC. | Logan Township, NJ, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| James Alexander Corp. | Blairstown, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Key Scientific Products | Stamford, TX, United States | 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.