Data / Medical devices / Reagent, Leishmanii Serological / United States
FDA-registered makers of Reagent, Leishmanii Serological in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Reagent, Leishmanii Serological (product code LOO). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Reagent, Leishmanii Serological
- Product code
- LOO
- Country
- United States
Makers of Reagent, Leishmanii Serological in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Inbios International, Inc. | Seattle, WA, United States | Manufacturer | 1 | May 6, 2003 | 0 | 0 | 0 | api.fda.gov |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eiger Diagnostics, Inc. | Las Vegas, NV, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Life Diagnostics Inc. | Carlsbad, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Medical Usa Corporation | Somerset, NJ, United States | Manufacturer for export | 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.