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Data / Medical devices / Extractable Antinuclear Antibody, Antigen And Control

Extractable Antinuclear Antibody, Antigen And Control (LLL): 20 FDA-registered makers in 5 countries

20 establishments in 5 countries are registered with the FDA to make Extractable Antinuclear Antibody, Antigen And Control (product code LLL, Class 2, 21 CFR 866.5100). 17 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 182 510(k) clearances under this code, the latest on August 21, 2026, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Get every maker of this deviceMakers in the United StatesWatch this device
Product code
LLL
Device class
2
Regulation
866.5100
Medical specialty
Immunology

Makers by country

CountryMakers
United States11
Germany5
Sweden2
United Kingdom1
France1

Makers of Extractable Antinuclear Antibody, Antigen And 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
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer, Manufacturer for export24September 29, 2023000api.fda.gov
Hemagen Diagnostics, Inc.Baltimore, MD, United StatesManufacturer17June 5, 1995000api.fda.gov
IMMUNO CONCEPTS, NA, Ltd.Sacramento, CA, United StatesManufacturer8September 13, 1996010api.fda.gov
Gold Standard Diagnostics, LLCDavis, CA, United StatesRepackager or relabeler, Specification developer6April 8, 1997000api.fda.gov
Trinity Biotech USAJamestown, NY, United StatesManufacturer5January 12, 2000000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesComplaint file establishment, Manufacturer, Specification developer4April 5, 2000000api.fda.gov
Zeus Scientific LLCBranchburg, NJ, United StatesManufacturer, Repackager or relabeler3October 22, 2025000api.fda.gov
AESKU.DIAGNOSTICS GmbH&Co.KGWENDELSHEIM Rhineland-Palatinate, GermanyManufacturer2July 14, 2004000api.fda.gov
DRG Instruments GMBHMARBURG Hesse, GermanyComplaint file establishment, Manufacturer2March 20, 1996000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer, Manufacturer for export2February 22, 1995000api.fda.gov
Phadia ABUppsala, SwedenComplaint file establishment, Manufacturer2June 25, 2026000api.fda.gov
Euroimmun Medizinische Labordiagnostika AGLuebeck Schleswig-Holstein, GermanyManufacturer1April 9, 2013000api.fda.gov
EUROIMMUN Medizinische Labordiagnostika AGDassow Mecklenburg-Western Pomerania, GermanyManufacturer1April 9, 2013000api.fda.gov
Immco Diagnostics, Inc.Williamsville, NY, United StatesManufacturer1March 31, 2015000api.fda.gov
Immunodiagnostic Systems Ltd.Boldon Colliery Durham, United KingdomManufacturer1August 21, 2026000api.fda.gov
Phadia ABUppsala, SwedenContract manufacturer, Manufacturer1June 25, 2026000api.fda.gov
TheradiagMARNE LA VALLEE CEDEX 2 Seine-et-Marne, FranceManufacturer1March 13, 2006000api.fda.gov
Calbiotech, Inc.El Cajon, CA, United StatesContract manufacturer0000api.fda.gov
Phadia GMBHFREIBURG Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Theratest Laboratories, Inc.Lombard, IL, United StatesManufacturer0000api.fda.gov

Updated August 21, 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.