Data / Medical devices / Radioimmunoassay, Cortisol
Radioimmunoassay, Cortisol (CGR): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Radioimmunoassay, Cortisol (product code CGR, Class 2, 21 CFR 862.1205). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 84 510(k) clearances under this code, the latest on March 5, 2025, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CGR
- Device class
- 2
- Regulation
- 862.1205
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| United Kingdom | 3 |
| Japan | 1 |
| Germany | 1 |
Makers of Radioimmunoassay, Cortisol
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 |
|---|---|---|---|---|---|---|---|---|
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 3 | March 5, 2025 | 0 | 2 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 2 | January 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Immunodiagnostic Systems Ltd. | Boldon Colliery Durham, United Kingdom | Manufacturer | 1 | April 13, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | July 3, 2006 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 1 | July 3, 2006 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter Mishima K.K. | SUNTO-GUN Shizuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 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 | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 5, 2025. 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.