Data / Medical devices / Calprotectin, Fecal
Calprotectin, Fecal (NXO): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Calprotectin, Fecal (product code NXO, Class 2, 21 CFR 866.5180). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on February 6, 2024, and lists 2 recall events (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
- NXO
- Device class
- 2
- Regulation
- 866.5180
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Italy | 1 |
| Switzerland | 1 |
Makers of Calprotectin, Fecal
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 |
|---|---|---|---|---|---|---|---|---|
| Eurospital S.P.A. | Trieste, Italy | Contract manufacturer, Manufacturer | 5 | July 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Buhlmann Laboratories AG | SCHONENBUCH/BASEL Basel-Landschaft, Switzerland | Complaint file establishment, Manufacturer | 4 | February 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 3 | July 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| American Laboratory Products Company | Salem, NH, United States | Manufacturer | 2 | April 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer | 2 | July 26, 2022 | 0 | 1 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 6, 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.