Data / Medical devices / Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (DBM): 12 FDA-registered makers in 3 countries
12 establishments in 3 countries are registered with the FDA to make Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM, Class 2, 21 CFR 866.5090). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on July 13, 2018, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DBM
- Device class
- 2
- Regulation
- 866.5090
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 3 |
| Sweden | 2 |
Makers of Antimitochondrial 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Phadia AB | Uppsala, Sweden | Complaint file establishment, Manufacturer | 2 | July 13, 2018 | 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 |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 1 | September 2, 2010 | 0 | 0 | 0 | api.fda.gov |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 1 | September 2, 2010 | 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 |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Svar Life Science AB | MALMO Skane, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 13, 2018. 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.