Data / Medical devices / System, Test, Anticardiolipin Immunological
System, Test, Anticardiolipin Immunological (MID): 18 FDA-registered makers in 4 countries
18 establishments in 4 countries are registered with the FDA to make System, Test, Anticardiolipin Immunological (product code MID, Class 2, 21 CFR 866.5660). 14 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 94 510(k) clearances under this code, the latest on December 17, 2024, and lists 13 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MID
- Device class
- 2
- Regulation
- 866.5660
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| Germany | 3 |
| Sweden | 2 |
| Spain | 1 |
Makers of System, Test, Anticardiolipin Immunological
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, Repackager or relabeler, Specification developer | 8 | December 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 6 | June 2, 1998 | 0 | 0 | 0 | api.fda.gov |
| Corgenix, Inc. | Broomfield, CO, United States | Manufacturer, Repackager or relabeler | 5 | October 14, 2003 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 4 | December 12, 2011 | 0 | 2 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 3 | June 2, 1998 | 0 | 0 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 3 | June 3, 1997 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 2 | October 21, 2013 | 0 | 0 | 0 | api.fda.gov |
| IMMUNO CONCEPTS, NA, Ltd. | Sacramento, CA, United States | Manufacturer | 2 | July 6, 1993 | 0 | 0 | 0 | api.fda.gov |
| Louisville Apl Diagnostics, Inc. | Texas City, TX, United States | Manufacturer | 2 | August 27, 2002 | 0 | 3 | 0 | api.fda.gov |
| Phadia AB | Uppsala, Sweden | Complaint file establishment, Manufacturer | 2 | December 23, 2013 | 0 | 0 | 0 | api.fda.gov |
| AESKU.DIAGNOSTICS GmbH&Co.KG | WENDELSHEIM Rhineland-Palatinate, Germany | Manufacturer | 1 | May 12, 2004 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Manufacturer, Specification developer | 1 | March 11, 2010 | 0 | 0 | 0 | api.fda.gov |
| Phadia AB | Uppsala, Sweden | Contract manufacturer, Manufacturer | 1 | June 7, 2010 | 0 | 0 | 0 | api.fda.gov |
| Theratest Laboratories, Inc. | Lombard, IL, United States | Manufacturer | 1 | February 7, 2006 | 0 | 1 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phadia GMBH | FREIBURG Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 17, 2024. 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.