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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.

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Product code
NBC
Device class
2
Regulation
862.1117
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States13
Japan3
Germany2
United Kingdom2
Canada2
Ireland1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Manufacturer for export, Specification developer6September 24, 2023030api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer5September 24, 2023010api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyManufacturer4July 21, 2023000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer, Manufacturer for export4September 24, 2023040api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesManufacturer3March 24, 2026000api.fda.gov
Quidel Cardiovascular Inc.San Diego, CA, United StatesManufacturer, Manufacturer for export3September 22, 2005000api.fda.gov
Axis-Shield Diagnostics, Ltd.DUNDEE Scotland, United KingdomManufacturer2February 18, 2026000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer2October 4, 2021000api.fda.gov
Ortho-Clinical DiagnosticsPencoed Bridgend, United KingdomManufacturer2October 4, 2021020api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesManufacturer, Specification developer2August 17, 2007010api.fda.gov
ABBOTT GmbHWiesbaden Hesse, GermanySpecification developer1May 25, 2006000api.fda.gov
Abbott Point Of Care Canada LimitedOttawa Ontario, CanadaManufacturer1July 21, 2006000api.fda.gov
PHC CorporationTako-machi Katori-gun Chiba, JapanComplaint file establishment, Specification developer1February 5, 2008000api.fda.gov
Response Biomedical Corp.Vancouver British Columbia, CanadaManufacturer1July 21, 2008000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.SWORDS Dublin(County), IrelandManufacturer1September 9, 2003000api.fda.gov
Tosoh Aia, Inc.Toyama, JapanManufacturer1August 24, 2020000api.fda.gov
Abbott Point Of Care Inc.Princeton, NJ, United StatesManufacturer, Specification developer0010api.fda.gov
CTK Biotech, Inc.Poway, CA, United StatesManufacturer for export0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov
Fujirebio Diagnostics, Inc.Malvern, PA, United StatesContract manufacturer0000api.fda.gov
Nano-Ditech CorporationCranbury, NJ, United StatesManufacturer for export0000api.fda.gov
Nipro Corporation Odate FactoryODATE-SHI Akita, JapanContract manufacturer0000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer for export0000api.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.