Data / Medical devices / Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (DHN): 19 FDA-registered makers in 3 countries
19 establishments in 3 countries are registered with the FDA to make Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN, Class 2, 21 CFR 866.5100). 19 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 110 510(k) clearances under this code, the latest on April 29, 2022, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DHN
- Device class
- 2
- Regulation
- 866.5100
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 15 |
| Germany | 3 |
| Italy | 1 |
Makers of Antinuclear Antibody, Indirect Immunofluorescent, 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 3 | April 17, 2015 | 0 | 0 | 0 | api.fda.gov |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 3 | April 17, 2015 | 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 |
| AESKU.DIAGNOSTICS GmbH&Co.KG | WENDELSHEIM Rhineland-Palatinate, Germany | Manufacturer | 2 | July 28, 2016 | 0 | 0 | 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 |
| Visia Lab SRL | SAN GIOVANNI VALDARNO Arezzo, Italy | Manufacturer | 1 | April 29, 2022 | 0 | 0 | 0 | api.fda.gov |
Updated April 29, 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.