Data / Medical devices / System, Test, Thyroglobulin
System, Test, Thyroglobulin (MSW): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make System, Test, Thyroglobulin (product code MSW, Class 2, 21 CFR 866.6010). 5 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on June 20, 2025, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MSW
- Device class
- 2
- Regulation
- 866.6010
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| United Kingdom | 1 |
| Germany | 1 |
| Japan | 1 |
Makers of System, Test, Thyroglobulin
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 | June 28, 2024 | 0 | 2 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer, Specification developer | 3 | June 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | June 20, 2025 | 0 | 2 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 1 | September 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 1 | June 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Fujirebio Diagnostics, Inc. | Malvern, PA, 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 | |
| Sibel Health Inc. | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 20, 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.