Data / Medical devices / Reagent, Leishmanii Serological
Reagent, Leishmanii Serological (LOO): 7 FDA-registered makers in 2 countries
7 establishments in 2 countries are registered with the FDA to make Reagent, Leishmanii Serological (product code LOO, Class 1, 21 CFR 866.3870). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on May 6, 2003, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LOO
- Device class
- 1
- Regulation
- 866.3870
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| India | 1 |
Makers of Reagent, Leishmanii Serological
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 |
|---|---|---|---|---|---|---|---|---|
| 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 Corporation Private Limited | VALSAD Gujarat, India | 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 May 6, 2003. 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.