Data / Medical devices / Test, Natriuretic Peptide
Test, Natriuretic Peptide (NBC): 23 FDA-registered makers in 6 countries
23 establishments in 6 countries are registered with the FDA to make Test, Natriuretic Peptide (product code NBC, Class 2, 21 CFR 862.1117). 16 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 47 510(k) clearances under this code, the latest on October 20, 2026, and lists 18 recall events (1 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
- NBC
- Device class
- 2
- Regulation
- 862.1117
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Japan | 3 |
| Germany | 2 |
| United Kingdom | 2 |
| Canada | 2 |
| Ireland | 1 |
Makers of Test, Natriuretic Peptide
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Manufacturer for export, Specification developer | 6 | September 24, 2023 | 0 | 3 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 5 | September 24, 2023 | 0 | 1 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 4 | July 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer, Manufacturer for export | 4 | September 24, 2023 | 0 | 4 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 3 | March 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Quidel Cardiovascular Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 3 | September 22, 2005 | 0 | 0 | 0 | api.fda.gov |
| Axis-Shield Diagnostics, Ltd. | DUNDEE Scotland, United Kingdom | Manufacturer | 2 | February 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 2 | October 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 2 | October 4, 2021 | 0 | 2 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Manufacturer, Specification developer | 2 | August 17, 2007 | 0 | 1 | 0 | api.fda.gov |
| ABBOTT GmbH | Wiesbaden Hesse, Germany | Specification developer | 1 | May 25, 2006 | 0 | 0 | 0 | api.fda.gov |
| Abbott Point Of Care Canada Limited | Ottawa Ontario, Canada | Manufacturer | 1 | July 21, 2006 | 0 | 0 | 0 | api.fda.gov |
| PHC Corporation | Tako-machi Katori-gun Chiba, Japan | Complaint file establishment, Specification developer | 1 | February 5, 2008 | 0 | 0 | 0 | api.fda.gov |
| Response Biomedical Corp. | Vancouver British Columbia, Canada | Manufacturer | 1 | July 21, 2008 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 1 | September 9, 2003 | 0 | 0 | 0 | api.fda.gov |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 1 | August 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 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 | |
| Fujirebio Diagnostics, Inc. | Malvern, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nipro Corporation Odate Factory | ODATE-SHI Akita, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 20, 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.