Data / Medical devices / Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB): 21 FDA-registered makers in 5 countries
21 establishments in 5 countries are registered with the FDA to make Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (product code MOB, Class 2, 21 CFR 866.5660). 18 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 75 510(k) clearances under this code, the latest on August 21, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MOB
- Device class
- 2
- Regulation
- 866.5660
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Germany | 4 |
| Sweden | 2 |
| France | 1 |
| Italy | 1 |
Makers of Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
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 |
|---|---|---|---|---|---|---|---|---|
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 7 | February 3, 2017 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 7 | August 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 5 | May 24, 2018 | 0 | 0 | 0 | api.fda.gov |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 5 | May 24, 2018 | 0 | 0 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 4 | February 17, 1998 | 0 | 0 | 0 | api.fda.gov |
| IMMUNO CONCEPTS, NA, Ltd. | Sacramento, CA, United States | Manufacturer | 4 | November 14, 2001 | 0 | 0 | 0 | api.fda.gov |
| AESKU.DIAGNOSTICS GmbH&Co.KG | WENDELSHEIM Rhineland-Palatinate, Germany | Manufacturer | 3 | March 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 3 | April 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 3 | November 13, 1997 | 0 | 0 | 0 | api.fda.gov |
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Manufacturer | 3 | October 7, 2010 | 0 | 0 | 0 | api.fda.gov |
| Gold Standard Diagnostics, LLC | Davis, CA, United States | Repackager or relabeler, Specification developer | 2 | November 18, 1998 | 0 | 0 | 0 | api.fda.gov |
| Phadia AB | Uppsala, Sweden | Complaint file establishment, Manufacturer | 2 | March 13, 2018 | 0 | 1 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 2 | August 19, 1996 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 1 | November 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Phadia AB | Uppsala, Sweden | Manufacturer | 1 | October 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| Theradiag | MARNE LA VALLEE CEDEX 2 Seine-et-Marne, France | Manufacturer | 1 | March 2, 2006 | 0 | 0 | 0 | api.fda.gov |
| Theratest Laboratories, Inc. | Lombard, IL, United States | Manufacturer | 1 | July 20, 2006 | 0 | 0 | 0 | api.fda.gov |
| Visia Lab SRL | SAN GIOVANNI VALDARNO Arezzo, Italy | Manufacturer | 1 | May 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.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.