Data / Medical devices / Antinuclear Antibody, Antigen, Control
Antinuclear Antibody, Antigen, Control (LKJ): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make Antinuclear Antibody, Antigen, Control (product code LKJ, Class 2, 21 CFR 866.5100). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 50 510(k) clearances under this code, the latest on July 27, 2022, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LKJ
- Device class
- 2
- Regulation
- 866.5100
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Sweden | 2 |
| Germany | 2 |
| France | 1 |
Makers of Antinuclear Antibody, Antigen, 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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 3 | July 9, 2012 | 0 | 6 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 2 | August 2, 1989 | 0 | 0 | 0 | api.fda.gov |
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Manufacturer | 2 | October 27, 1988 | 0 | 0 | 0 | api.fda.gov |
| Phadia AB | Uppsala, Sweden | Complaint file establishment, Manufacturer | 2 | July 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| AESKU.DIAGNOSTICS GmbH&Co.KG | WENDELSHEIM Rhineland-Palatinate, Germany | Manufacturer | 1 | May 2, 2008 | 0 | 0 | 0 | api.fda.gov |
| Gold Standard Diagnostics, LLC | Davis, CA, United States | Repackager or relabeler, Specification developer | 1 | October 25, 1999 | 0 | 0 | 0 | api.fda.gov |
| IMMUNO CONCEPTS, NA, Ltd. | Sacramento, CA, United States | Manufacturer | 1 | May 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 1 | October 8, 2004 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phadia AB | Uppsala, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phadia GMBH | FREIBURG Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theradiag | MARNE LA VALLEE CEDEX 2 Seine-et-Marne, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 27, 2022. 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.