Data / Medical devices / Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control / United States
FDA-registered makers of Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- Product code
- DBM
- Country
- United States
Makers of Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 4 | June 15, 1983 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 2 | June 15, 1983 | 0 | 0 | 0 | api.fda.gov |
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 2 | September 5, 2017 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Manufacturer | 1 | April 14, 1981 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Manufacturer | 1 | April 14, 1981 | 0 | 0 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 1 | June 20, 1997 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 1 | May 3, 1994 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.