Data / Medical devices / Radioimmunoassay (Two-Site Solid Phase), Ferritin
Radioimmunoassay (Two-Site Solid Phase), Ferritin (JMG): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Radioimmunoassay (Two-Site Solid Phase), Ferritin (product code JMG, Class 2, 21 CFR 866.5340). 5 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on March 20, 2024, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JMG
- Device class
- 2
- Regulation
- 866.5340
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 2 |
| United Kingdom | 1 |
| Ireland | 1 |
Makers of Radioimmunoassay (Two-Site Solid Phase), Ferritin
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 | 2 | March 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 1 | June 2, 1997 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 1 | January 24, 1997 | 0 | 3 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 1 | January 13, 1993 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | January 13, 1993 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, 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 | |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 20, 2024. 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.