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Data / Medical devices / Kappa, Antigen, Antiserum, Control

Kappa, Antigen, Antiserum, Control (DFH): 15 FDA-registered makers in 8 countries

15 establishments in 8 countries are registered with the FDA to make Kappa, Antigen, Antiserum, Control (product code DFH, Class 2, 21 CFR 866.5550). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 63 510(k) clearances under this code, the latest on December 19, 2025, 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
DFH
Device class
2
Regulation
866.5550
Medical specialty
Immunology

Makers by country

CountryMakers
United States6
United Kingdom2
Italy2
Germany1
France1
Denmark1
Singapore1
Netherlands1

Makers of Kappa, Antigen, Antiserum, Control

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, Manufacturer7May 23, 2025000api.fda.gov
The Binding Site Group Ltd.Birmingham, United KingdomComplaint file establishment, Manufacturer7May 23, 2025020api.fda.gov
Siemens Healthcare Diagnostics Products GmbHMARBURG Hesse, GermanyManufacturer6March 2, 2022000api.fda.gov
The Binding Site, Inc.San Diego, CA, United StatesManufacturer4May 23, 2025000api.fda.gov
SebiaEVRY Essonne, FranceManufacturer3February 23, 2024000api.fda.gov
Agilent Technologies Denmark ApSGLOSTRUP Hovedstaden, DenmarkManufacturer1September 29, 1981000api.fda.gov
Agilent Technologies Singapore (International) Pte Ltd.Singapore North East, SingaporeSpecification developer1September 29, 1981000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer1February 10, 1997000api.fda.gov
Diazyme Laboratories, Inc.Poway, CA, United StatesManufacturer1June 26, 2018000api.fda.gov
Sentinel CH. SPAMilano, ItalyManufacturer1September 3, 2009000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Essange ReagentsAmsterdam Noord-Holland, NetherlandsContract manufacturer0000api.fda.gov
Helena Laboratories, Corp.Beaumont, TX, United StatesManufacturer0000api.fda.gov
Interlab S.R.L.ROME Lazio, ItalyManufacturer0000api.fda.gov
Kent Laboratories, Inc.Bellingham, WA, United StatesManufacturer0000api.fda.gov

Updated December 19, 2025. 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.