Data / Medical devices / Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control / United States
FDA-registered makers of Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN). 15 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- Product code
- DHN
- Country
- United States
Makers of Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| IMMUNO CONCEPTS, NA, Ltd. | Sacramento, CA, United States | Manufacturer | 8 | June 17, 2016 | 0 | 1 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 7 | April 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Specification developer | 6 | January 17, 2003 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Specification developer | 6 | January 17, 2003 | 0 | 0 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 4 | December 5, 1996 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 3 | January 2, 1990 | 0 | 0 | 0 | api.fda.gov |
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 3 | April 8, 2015 | 0 | 1 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer, Manufacturer | 2 | January 18, 1982 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Manufacturer | 2 | January 18, 1982 | 0 | 0 | 0 | api.fda.gov |
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Manufacturer | 2 | June 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Antibodies Incorporated | Davis, CA, United States | Manufacturer | 1 | September 1, 1981 | 0 | 0 | 0 | api.fda.gov |
| Antibodies Incorporated | Davis, CA, United States | Manufacturer | 1 | September 1, 1981 | 0 | 0 | 0 | api.fda.gov |
| Bion Enterprises, Ltd. | Des Plaines, IL, United States | Contract manufacturer, Manufacturer | 1 | August 17, 1987 | 0 | 0 | 0 | api.fda.gov |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer | 1 | April 5, 1977 | 0 | 2 | 0 | api.fda.gov |
| Euroimmun Us Inc. | Mountain Lakes, NJ, United States | Complaint file establishment, Contract manufacturer | 1 | May 22, 2007 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.