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Data / Medical devices / Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls (LJM): 18 FDA-registered makers in 4 countries

18 establishments in 4 countries are registered with the FDA to make Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls (product code LJM, Class 2, 21 CFR 866.5100). 13 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 112 510(k) clearances under this code, the latest on November 27, 2018, 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
LJM
Device class
2
Regulation
866.5100
Medical specialty
Immunology

Makers by country

CountryMakers
United States10
Germany5
Sweden2
France1

Makers of Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

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
DRG Instruments GMBHMARBURG Hesse, GermanyComplaint file establishment, Manufacturer10May 2, 2003000api.fda.gov
Theratest Laboratories, Inc.Lombard, IL, United StatesManufacturer4March 11, 2004000api.fda.gov
Trinity Biotech USAJamestown, NY, United StatesManufacturer4May 2, 1994000api.fda.gov
Zeus Scientific LLCBranchburg, NJ, United StatesManufacturer3June 10, 1994010api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2July 18, 1995000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer2June 10, 1994000api.fda.gov
IMMUNO CONCEPTS, NA, Ltd.Sacramento, CA, United StatesManufacturer2July 23, 1999000api.fda.gov
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer2February 7, 2014000api.fda.gov
Phadia ABUppsala, SwedenComplaint file establishment, Manufacturer2November 27, 2018000api.fda.gov
Euroimmun Medizinische Labordiagnostika AGLuebeck Schleswig-Holstein, GermanyManufacturer1July 15, 2013000api.fda.gov
EUROIMMUN Medizinische Labordiagnostika AGDassow Mecklenburg-Western Pomerania, GermanyManufacturer1July 15, 2013000api.fda.gov
GenbioSan Diego, CA, United StatesManufacturer1December 5, 1989000api.fda.gov
Hemagen Diagnostics, Inc.Baltimore, MD, United StatesManufacturer1March 17, 1992000api.fda.gov
AESKU.DIAGNOSTICS GmbH&Co.KGWENDELSHEIM Rhineland-Palatinate, GermanyManufacturer0000api.fda.gov
Immunocentrix CorporationCanoga Park, CA, United StatesManufacturer for export0000api.fda.gov
Phadia ABUppsala, SwedenContract manufacturer0000api.fda.gov
Phadia GMBHFREIBURG Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
TheradiagMARNE LA VALLEE CEDEX 2 Seine-et-Marne, FranceManufacturer0000api.fda.gov

Updated November 27, 2018. 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.