Data / Medical devices / System, Test, Anticardiolipin Immunological / United States
FDA-registered makers of System, Test, Anticardiolipin Immunological in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make System, Test, Anticardiolipin Immunological (product code MID). 10 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
- System, Test, Anticardiolipin Immunological
- Product code
- MID
- Country
- United States
Makers of System, Test, Anticardiolipin Immunological in the United States
| 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 |
| 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 |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Manufacturer, Specification developer | 1 | March 11, 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 | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 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.