Data / Medical devices / Radioimmunoassay, Aldosterone
Radioimmunoassay, Aldosterone (CJM): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Radioimmunoassay, Aldosterone (product code CJM, Class 2, 21 CFR 862.1045). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on April 21, 2015, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CJM
- Device class
- 2
- Regulation
- 862.1045
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| United Kingdom | 1 |
| Czechia | 1 |
Makers of Radioimmunoassay, Aldosterone
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 |
|---|---|---|---|---|---|---|---|---|
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer | 1 | April 9, 2013 | 0 | 0 | 0 | api.fda.gov |
| Immunodiagnostic Systems Ltd. | Boldon Colliery Durham, United Kingdom | Manufacturer | 1 | April 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| IMMUNOTECH s.r.o. | Prague Praha, Hlavni Mesto, Czechia | Manufacturer | 1 | February 13, 1995 | 0 | 0 | 0 | api.fda.gov |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 21, 2015. 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.