Data / Medical devices / Immunoassay Blood Test For Amyloid Pathology Assessment
Immunoassay Blood Test For Amyloid Pathology Assessment (SET): 4 FDA-registered makers in 4 countries
4 establishments in 4 countries are registered with the FDA to make Immunoassay Blood Test For Amyloid Pathology Assessment (product code SET, Class 2, 21 CFR 866.5840). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on August 19, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- SET
- Device class
- 2
- Regulation
- 866.5840
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| Germany | 1 |
| United States | 1 |
| Belgium | 1 |
| Japan | 1 |
Makers of Immunoassay Blood Test For Amyloid Pathology Assessment
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 |
|---|---|---|---|---|---|---|---|---|
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 2 | August 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| Fujirebio Diagnostics, Inc. | Malvern, PA, United States | Manufacturer | 1 | May 16, 2025 | 0 | 1 | 0 | api.fda.gov |
| Fujirebio Europe N.V. | GHENT Oost-Vlaanderen, Belgium | Manufacturer | 1 | May 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Fujirebio Inc. | Sagamihara-shi Kanagawa, Japan | Manufacturer | 1 | May 16, 2025 | 0 | 0 | 0 | api.fda.gov |
Updated August 19, 2026. 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.