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Data / Medical devices / Method, Nephelometric, Immunoglobulins (G, A, M)

Method, Nephelometric, Immunoglobulins (G, A, M) (CFN): 14 FDA-registered makers in 6 countries

14 establishments in 6 countries are registered with the FDA to make Method, Nephelometric, Immunoglobulins (G, A, M) (product code CFN, Class 2, 21 CFR 866.5510). 9 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 61 510(k) clearances under this code, the latest on December 13, 2023, and lists 12 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
CFN
Device class
2
Regulation
866.5510
Medical specialty
Immunology

Makers by country

CountryMakers
United States5
United Kingdom3
Germany3
Ireland1
France1
Switzerland1

Makers of Method, Nephelometric, Immunoglobulins (G, A, M)

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
The Binding SiteKings Norton Birmingham, United KingdomComplaint file establishment, Manufacturer, Repackager or relabeler16August 19, 2019000api.fda.gov
The Binding Site Group Ltd.Birmingham, United KingdomComplaint file establishment, Manufacturer16August 19, 2019050api.fda.gov
Siemens Healthcare Diagnostics Products GmbHMARBURG Hesse, GermanyManufacturer7December 13, 2023000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandManufacturer3February 11, 2008000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer2January 7, 2014030api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler1November 10, 2004000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1November 10, 2004000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler1September 28, 1998000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer1April 29, 2009010api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Horiba Abx SASMONTPELLIER Herault, FranceSpecification developer0000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov

Updated December 13, 2023. 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.